Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Rare Diseases

Syndrome

Leukemia

Preleukemia

Leukemia, Myelomonocytic, Chronic

Leukemia, Myelomonocytic, Juvenile

Myelodysplastic Syndromes

Neoplasms by Histologic Type

Hematologic Diseases

Bone Marrow Diseases

Precancerous Conditions

Leukemia, Myeloid

Myeloproliferative Disorders

Myelodysplastic-Myeloproliferative Diseases

Chronic Disease

Disease Attributes

Chronic Myelomonocytic Leukemia

Juvenile Myelomonocytic Leukemia

Chronic Graft Versus Host Disease

Chronic Myeloproliferative Disorders

Myelodysplastic/myeloproliferative Disease

Anti-Infective Agents

All Drugs and Chemicals

Antineoplastic Agents

Analgesics

Micronutrients

Anti-Bacterial Agents

Cytarabine

Mitoxantrone

Iron

Daunorubicin

Antibiotics, Antitubercular

Mitogens

Clotrimazole

Miconazole

Idarubicin

Antifungal Agents

Iron Chelating Agents

Guadecitabine

Participants received Guadecitabine 60 mg/m\^2, SC, on Days 1-5 of each 28-day cycle for at least 6 cycles in the absence of unacceptable toxicity or disease progression requiring alternative therapy. Participants received Guadecitabine treatment beyond 6 cycles as long as the participant continued to benefit based on investigator judgment and participant response and tolerability (or up to a maximum of 36 cycles).

Participants received one of the three treatment choice options:

1. LDAC 20 mg/m\^2 SC/IV once daily for 14 days of each 28-day cycles for at least 4 cycles in absence of disease progression or unacceptable toxicity.Participants who were responding or had stable disease were to continue treatment as per standard institutional practice.
2. Standard IC of a 7+3 regimen:Cytarabine 100-200 mg/m\^2/day given as continuous infusion for 7 days and anthracycline(daunorubicin(45-60 mg)/idarubicin(9-12 mg)/mitoxantrone(8-12 mg)/m\^2) by IV infusion for 3 days of each 28-day cycles.
3. BSC as needed during the treatment included,but was not limited to,blood transfusions(RBCs or platelets),growth factors including erythropoiesis stimulating agents,granulocyte stimulating factors,iron chelating therapy,and broad-spectrum antibiotics and/or antifungals.

Duration for treatment choice was as per locally approved prescribing information and institutional standard practice or up to a maximum 30 cycles.

* BSC: according to standard/institutional practice; included RBC or platelet transfusions; growth factors, i.e. erythropoiesis stimulating agents, granulocyte stimulating factors, iron chelating therapy; broad spectrum antibiotics and/or antifungals.
* LDAC: 20 mg/m\^2 SC or IV once daily (QD) for 14 days in 28-day cycles. Other schedules were allowed per institutional practice. Treatment for ≥4 cycles absent disease progression/toxicity. BSC per institutional/standard practice.
* Standard Intensive Chemotherapy: recommended regimen of 7+3 was given as cytarabine 100-200 mg/m\^2/day continuous infusion for 7 days and an anthracycline for 3 days. Anthracyclines per institutional practice included daunorubicin (45-60 mg/m\^2/day) or idarubicin (9-12 mg/m\^2/day) or mitoxantrone (8-12 mg/m\^2/day) by IV infusion. Participants with complete or partial response after IC induction received ≥1 additional cycles with reduced cytotoxic doses then BSC per standard /institutional practice.

Treatment Choice

Yuri Sano, MD, PhD

A Phase 3, randomized, open-label, parallel-group, multicenter study designed to evaluate the efficacy and safety of guadecitabine in participants with MDS or CMML who failed or relapsed after adequate prior treatment with azacitidine, decitabine, or both. This global study will be conducted in approximately 15 countries. Approximately 408 participants from approximately 100 study centers will be randomly assigned in a 2:1 ratio to either guadecitabine (approximately 272 participants) or Treatment Choice (approximately 136 participants). The study consists of a 21-day screening period, a treatment period, a safety follow-up visit, and a long-term follow-up period. The study is expected to last more than 2 years, and the duration of individual participant participation will vary. Participants may continue to receive treatment for as long as they continue to benefit.

Multicenter, randomized, open-label, parallel-group study of guadecitabine vs Treatment Choice (TC). Approximately 408 participants will be randomly assigned 2:1 to either guadecitabine or TC.

* Guadecitabine: approximately 272 participants.
* TC: approximately 136 participants.

Before randomization, the investigator will assign each participant to one of the following TC options:

* Low dose cytarabine (LDAC).
* Standard Intensive Chemotherapy (IC) of a 7+3 regimen.
* Best Supportive Care (BSC) only. BSC will be provided to all participants as per standard and institutional practice. Participants randomized to TC will not be allowed to cross over to guadecitabine. Data will be reviewed by an independent Data Monitoring Committee at regular intervals, primarily to evaluate safety during study conduct. Randomization will be stratified by disease category (MDS vs CMML), bone marrow (BM) blasts (BM blasts \>10% vs BM blasts ≤10%), TC option (LDAC vs IC vs BSC), and study center region.

Guadecitabine: 60 milligrams per square meter (mg/m\^2) given subcutaneously (SC) daily on Days 1-5 in 28-day cycles (delayed as needed to allow blood count recovery). Treatment should be given for at least 6 total cycles in the absence of unacceptable toxicity or disease progression requiring alternative therapy. Beyond 6 cycles, treatment should continue as long as the participant continues to benefit. BSC should be given according to standard and institutional practice.

Treatment Choice (TC): Before randomization, the investigator will assign each participant to one of the following TC options:

* Low dose cytarabine (LDAC) given as 20 mg/m\^2 SC or intravenously (IV) once daily for 14 days in 28-day cycles (delayed as needed to allow blood count recovery). Treatment should be given for at least 4 cycles in the absence of disease progression or unacceptable toxicity.
* Standard Intensive Chemotherapy (IC) of a 7+3 regimen: given as cytarabine 100-200 mg/m\^2/day given as continuous infusion for 7 days and an anthracycline given as per institutional standard practice such as daunorubicin (45-60 mg/m\^2/day), or idarubicin (9-12 mg/m\^2/day), or mitoxantrone (8-12 mg/m\^2/day) by intravenous infusion for 3 days.
* Best Supportive Care (BSC) only: given according to standard and institutional practice. BSC includes, but is not limited to blood transfusions (Red blood cells \[RBCs\] or platelets), growth factors including erythropoiesis stimulating agents (ESA), granulocyte stimulating factors (GSFs), iron chelating therapy, and broad-spectrum antibiotics and/or antifungals.

Guadecitabine (SGI-110) vs Treatment Choice in Adults With MDS or CMML Previously Treated With HMAs

A Phase 3, Multicenter, Randomized, Open-Label Study of Guadecitabine (SGI-110) Versus Treatment Choice in Adults With Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML) Previously Treated With Hypomethylating Agents

OS was defined as the number of days from the day the participant was randomized to the date of death due to any cause. Survival time was censored on the last date the participant is known alive with no event of death. OS time will be estimated using the Kaplan-Meier method.

Transfusion independence rate was calculated as the number of participants with neither RBC nor platelet transfusion for any period of 8 weeks after the initiation of treatment (or cycle 1 day 1 { C1D1} visit date for participants randomized to BSC or randomization date for participants not treated) and up to treatment discontinuation (or 180 days for participants discontinuing the treatment within 6 months), while maintaining haemoglobin (Hgb) ≥8 gram per deciliter (g/dL) and platelets ≥20×10\^9/liter (L) divided by the total number of participants included in the efficacy analysis. RBC or Platelet transfusion independence rate was defined similarly as above. Percentage of participants are rounded off to the single decimal point.

mCR was defined as per 2006 Myelodysplastic Syndromes International Council for Harmonisation (MDS IWG) criteria as reduction of bone marrow (BM) blasts to ≤5% and decrease by 50% or more with or without normalization of peripheral counts. Transfusion independence rate was calculated as the number of participants with neither RBC nor platelet transfusion for any period of 8 weeks after the initiation of treatment (or C1D1 visit date for participants randomized to BSC or randomization date for participants not treated) and up to treatment discontinuation (or 180 days for participants discontinuing the treatment within 6 months), while maintaining Hgb ≥8 g/dL and platelets ≥20×10\^9/L divided by the total number of participants included in the efficacy analysis. The percentage of participants who achieved mCR and transfusion independence simultaneously in the same period were calculated for each group. Percentage of participants are rounded off to the single decimal point.

One year survival rate was defined as the percentage of participants that survived at the end of the first year from randomization. Participants who did not have death in record were censored on the last date known to be alive. Percentage of participants are rounded off to the nearest whole number.

Leukemia-free survival was defined as the number of days from randomization to the earliest date when participants have bone marrow (BM) or peripheral blood (PB) blasts ≥20%, conversion to acute myeloid leukemia (AML) or death of any cause. Participants with no events in leukemia-free survival were censored on the last date of BM or PB blasts assessment, whichever is later. Survival time will be estimated using the Kaplan-Meier method.

The date of each hospital admission and discharge was collected for each participant for up to 6 months, unless the participant died or withdrew consent prior to that time. Duration of each hospital stay in days was calculated as date of discharge minus date of admission. The NDAOH within first 6 month period was calculated as: NDAOH 6M=180 -total duration of all hospital stays within 180 days from the first treatment -number of death days before Day 180. For participants who were lost to follow-up within 6 months, the NDAOH was calculated conservatively assuming that the participant would have died the day after the last contact day.

DR: Complete Response(CR), Partial Response(PR),Marrow Complete Response(mCR), and Hematological Improvement(HI) including HI with Erythroid (HI-E), HI with Neutrophil (HI-N), or HI with Platelet (HI-P) based on IWG 2006 criteria. CR: BM:≤5% myeloblasts, Peripheral blood: Hgb≥11g/dL, Platelets(PLTs)≥100x10\^9/L, Neutrophils≥1.0x10\^9/L, Blasts 0%. PR: All CR criteria if abnormal before treatment except BM blasts decreased ≥50% over pretreatment but still\>5%, Cellularity, morphology not relevant. HI responses:1) HI-E: Hgb increase ≥1.5g/dL, Relevant reduction of RBC units transfusions by absolute ≥4 RBC transfusions/8 week(wk) compared with pretreatment transfusion number previous 8wk. Only RBC transfusions given for Hgb≤9.0g/dL. 2) HI-P: Absolute increase≥30x10\^9/L starting\>20x10\^9/L PLTs; Increase from\<20x10\^9/L to\>20x10\^9/L and by≥100%. 3) HI-N: ≥100% increase, absolute increase\>0.5x10\^9/L.

Duration of complete response (in number of days) was calculated from the first time a CR was observed to the date of the earliest of the following three events: 1) relapse/disease progression, 2) start of alternative therapy (except Hematopoietic Cell Transplant \[HCT\]) or 3) death. In the absence of any event, the duration of CR was censored at the last available time point (BM assessment, PB assessment, or safety/long-term follow-up visit) at which an event was not observed. Duration of complete response was analysed using a Kaplan-Meier method for participants who achieved a CR during the study. CR: BM: ≤5% myeloblasts (all cell lines normal maturation), Peripheral blood: Hgb ≥11g/dL, PLTs ≥100x10\^9/L, Neutrophils ≥1.0x10\^9/L, Blasts 0%.

Time to first response was the time(days) from randomization to first date when any response was achieved. Time to CR was the time(days) from randomization to first date when CR was achieved. Time to best response was the time(days) from randomization to first date when participant's best response (CR,PR,mCR or HI) was achieved. CR:BM:≤5% myeloblasts, Peripheral blood:Hgb≥11g/dL,PLTs≥100x10\^9/L,Neutrophils≥1.0x10\^9/L,Blasts 0%. PR: All CR criteria except BM blasts decreased≥50% over pretreatment but still \>5%,Cellularity,morphology not relevant. mCR: Reduction of BM blasts to≤5%; decrease ≥50% with/without normalization of peripheral counts. HI responses:1)HI-E:Hgb increase≥1.5 g/dL, Relevant reduction of RBC units transfusions by absolute≥4 RBC transfusions/8wk compared with pretreatment transfusion number previous 8wk. 2)HI-P:Absolute increase≥30x10\^9/L starting\>20x10\^9/L PLTs; Increase from≤20 to\>20x10\^9/L and by≥100% 3)HI-N:≥100% granulocyte increase, absolute increase\>0.5x10\^9/L.

The total number of RBCs transfused or, separately, the total number of platelets transfused up to the 6-month time point for each participant was counted from the date of randomization to Day 180, the date of last contact, or date of death, whichever occurred earlier. One RBC or platelet transfusion was defined as one unit, and a single bag of RBCs or platelets was considered one unit. The mean total number of RBC or platelet units transfused per participant is presented.

The EQ-5D-5L is a self-reported health status questionnaire that consists of six questions used to calculate a health utility score for use in health economic analysis. There are two components to the EQ-5D-5L, first component is a descriptive system five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used to obtain an Index Utility Score, as well as a second component visual analogue scale (VAS) that measures health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. The health status is converted to an index value using the country-specific weighted scoring algorithm for England. The summary index value for the England ranges from a worst score of -0.281 to a best score of 1. An increase in the EQ-5D-5L total score indicates improvement.

The EQ-5D-5L is a self-reported health status questionnaire that consists of six questions used to calculate a health utility score for use in health economic analysis. The second component, EQ VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine).

An AE is defined as any untoward medical occurrence in a clinical investigation participants administered a drug; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization; results in persistent or significant disability; is congenital anomaly; is suspected transmission of any infectious agent via a medicinal product or is medically important. Treatment emergent AEs which are those with onset date on or after the date of the first dose of study drug on C1D1 until 30 days after the last dose of study treatment, or the start of an alternative anticancer treatment, whichever occurs first.

Number of deaths, regardless of cause, within 30 or 60 days from the first study dose divided by the total number of participants included in the Safety Analysis Set. Participants who died within 30 days were also included in the 60-day mortality calculations.

Astex Pharmaceuticals, Inc.

All-cause mortality:The Efficacy Analysis Set included all participants randomly assigned to study treatment.

Serious and other adverse events:The Safety Analysis Set included all participants randomly assigned to study treatment who received any amount of study treatment or any component of a multi-dose study treatment regimen.

As pre-specified in the protocol, participants were grouped, and data was collected according to treatment received (Guadecitabine/Treatment Choice)for adverse events.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

The Efficacy Analysis Set included all participants randomly assigned to the study treatment.

Dr. Yuri Sano, Study Director

Overall Survival (OS)

Transfusion Independence Rate (8 weeks)

Platelet Transfusion Independence Rate

RBC Transfusion Independence Rate

Percentage of Participants With Transfusion Independence for Any 8 Consecutive Weeks

Percentage of Participants With Marrow Complete Response (mCR) Along With Transfusion Independence Rate

Survival Rate at 1 Year After Randomization

Leukemia-free Survival

Number of Days Alive and Out of the Hospital (NDAOH)

Complete Response (CR)

Partial Response (PR)

Marrow Complete Response (mCR)

Hematological Improvement (HI)

HI with Erythroid (HI-E)

HI with Platelet (HI-P)

HI with Neutrophil (HI-N)

The Efficacy Analysis Set included all participants randomly assigned to the study treatment. Participants who had multiple responses of HI (HI-E, HI-N and HI-P) were counted only once while calculating the total HI value in both treatment groups. Percentage of participants are rounded off to the nearest single decimal point.

Disease Response (DR) Rate

The Efficacy Analysis Set included all participants randomly assigned to the study treatment. Overall number of participants analyzed are the number of participants with CR (responders) only.

Duration of Complete Response (CR)

Time to First Response (CR, PR, mCR, or HI)

Time to CR

Time to Best Response (CR, PR, mCR, or HI)

The Efficacy Analysis Set included all participants randomly assigned to the study treatment. Overall number of participants analyzed are the number of participants with data available for analysis. 'Number Analyzed' indicates the number of participants with response.

Time to First Response, Complete Response (CR) and Best Response

RBC Transfusions

Platelet Transfusions

Number of Red Blood Cell (RBC) and Platelet Transfusions

Baseline

Change from Baseline at Month 6

The Efficacy Analysis Set included all participants randomly assigned to the study treatment. Overall number of participants analyzed are the number of participants with data available for analysis. 'Number Analyzed' indicates the number of participants with data available for analysis at the given timepoint. As pre-specified in the statistical analysis plan (SAP), the analysis included only the data collected for each participant during the first 6 months of study participation.

Change From Baseline in Health-related Quality of Life (QOL) By EuroQol 5-level 5-dimension (EQ-5D-5L) Summary Index

Change From Baseline in Health-related QOL: EuroQOL Visual Analogue Scale (EQ-VAS) Score

TEAE

The Safety Analysis Set included all participants randomly assigned to study treatment who received any amount of study treatment or any component of a multi-dose study treatment regimen.

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Within 30 Days

Within 60 days

30-day and 60-day All-cause Mortality

Participants received Guadecitabine 60 milligrams per square meter (mg/m\^2), subcutaneously (SC), on Days 1-5 of each 28-day cycle for at least 6 cycles in the absence of unacceptable toxicity or disease progression requiring alternative therapy. Participants received Guadecitabine treatment beyond 6 cycles as long as the participant continued to benefit based on investigator judgment and participant response and tolerability (or up to a maximum of 36 cycles).

Participants received one of the three treatment choice options:

1. Low dose cytarabine (LDAC) 20 mg/m\^2 SC or intravenous (IV) once daily for 14 days of each 28-day cycles for at least 4 cycles in the absence of disease progression or unacceptable toxicity. Participants who were responding or had stable disease were to continue treatment as per standard and institutional practice.
2. Standard Intensive Chemotherapy (IC) of a 7+3 regimen: Cytarabine 100-200 mg/m\^2/day given as continuous infusion for 7 days and an anthracycline (daunorubicin (45-60 mg)/idarubicin (9-12 mg)/mitoxantrone (8-12 mg)/m\^2) by IV infusion for 3 days of each 28-day cycles.
3. Best Supportive Care (BSC) as needed during the treatment included, but was not limited to, blood transfusions (Red blood cells \[RBCs\] or platelets), growth factors including erythropoiesis stimulating agents, granulocyte stimulating factors, iron chelating therapy, and broad-spectrum antibiotics and/or antifungals.

Duration for treatment choice was as per locally approved prescribing information and institutional standard practice or up to a maximum 30 cycles.

Overall Study

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Oculocerebral Syndrome With Hypopigmentation

None - Common practice

The treatment landscape of metastatic non small cell lung cancer (NSCLC) is rapidly evolving. There are new diagnostic and treatment options available in the coming months and years.

New combination treatments will give different solutions to pneumo-oncologists who might be guided by certain patient and tumor characteristics.

The link between patient and tumor characteristics in untreated stage IV non small cell lung cancer (NSCLC) patients and systemic treatment needs further investigation, allowing the identification of possible treatment issues, data gaps and/or areas of improvement.

This is a multicenter, non-interventional, cross-sectional study. Consecutive patients with metastatic stage IV non small cell lung cancer (NSCLC) selected for systemic treatment or best supportive care will be included in the trial at the time the patient signed the informed consent form (ICF). Patients that were selected for systemic treatment, should have received at least their first dose and a maximum of one cycle of the same treatment.

The pneumo-oncologist that treats the patient will fill in the CRF, indicating the systemic treatment option and the link with the variable categories that impacted the choice for a systemic treatment option.

BEPACT- Lung: Impact of Patient Characteristics on Pneumo-oncologists Non Small Cell Lung Cancer (NSCLC) Systemic Treatment Decision in Belgium

BEPACT Lung: Impact of Patient Characteristics on Pneumo-oncologists Non Small Cell Lung Cancer (NSCLC) Systemic Treatment Decision in Belgium: A Cross-sectional Study

Systemic treatment choices are defined as :

1. Chemotherapy (chemo)
2. Immunotherapy (IO)
3. immuno combined therapies (IO+IO)
4. IO+chemo
5. IO+bevacizumab+chemo (IO+bev+chemo)
6. best supportive care (BSC). There is no exposure in this study.

MSD Belgium BVBA

Adverse Event Reporting INVESTIGATOR RESPONSIBILITY: If the investigator becomes aware of any serious adverse event (SAE), including death due to any cause, or non-serious adverse reaction (NSAR) following the use of any Merck product, the event must be reported according to Table 1. The investigator must evaluate each SAE for causality and record causality on the AE form for each event reported.

This is a primary data collection non-interventional study being conducted within routine medical practice.

All direction for medication usage is at the discretion of a physician in accordance with usual medical practice.

No administration of any therapeutic or prophylactic agent is required in this protocol, and there are no procedures required as part of this protocol.

Primary Study Group - Single Arm

A total of 215 patients were enrolled in the study and 209 qualified for inclusion in the Eligible Population (i.e. had given informed consent and satisfied all inclusion criteria and none of the exclusion criteria).

All analyses were performed on the Eligible Population.

* Demography data
* Age (years)
* Gender (male or female)
* Weight loss (%)
* Smoking status (current, former (defined as smoking ≥ 1 year), never, or unknown)
* ECOG status (0, 1, 2, 3-4, or unknown)
* Patient's preference for treatment choice (yes, no, or unknown)

Primary Study Group

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Histology of non small cell lung cancer patients can be divided in squamous, non-squamous, not otherwise specified.

Histology

The ECOG performance status is a scale used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. Ranging from 0 (fully active) to 5 (dead).

ECOG

Smoking status is definde as current, former (former smoker defined as ≥ 1 year), never, or unknown

Smoking Status

Clinical trials have shown the association of programmed cell death 1 (PD-L1) expression by immunohistochemistry (IHC) with higher overall response rates to the PD-1/PD-L1 axis blockade suggesting that PD-L1 expression may serve as a predictive marker.

IHC PD-L1

The experiment is not interventional and cross sectional.

Stephanie Coulon

Confirmed diagnosis of stage IV NSCLC on first-line (1L) systemic treatment

The Study Outcome is Defined as the Systemic Treatment Choice.

Stage IV untreated non-small cell lung cancer (NSCLC)

Patient disposition:

* Enrolled patients n=215
* Eligible patients n=209

Total of 215 patients were enrolled in the study at 21 different sites between 03 June 2019 and 31 October 2019.

Of the enrolled patients, 209 qualified for inclusion in the Eligible Population (i.e. had given informed consent and satisfied all inclusion criteria and none of the exclusion criteria)

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Breast cancer survivors recruited at the Kaplan Medical Center

Breast cancer survivors recruited at the Rambam Medical Center

Breast cancer survivors recruited at the Sheba Medical Center

Breast cancer survivors recruited at the Barzilai Medical Center

A detailed questionnaire inquiring about demand factors, supply factors and perceptions affecting patients' treatment choices in 5 key decision points: participation role in the decision making process, hospital choice, treatment regimen choice, surgical extent and surgeon choice.

Factors and perceptions questionnaire

Depth interviews with 20 breast cancer patients, 2 spouses and 3 staff members.

Qualitative interview

Shuli Brammli-Greenberg, PhD

Boaz Hovav, MD

A Multi-center Cross-sectional quantitative study with a preliminary qualitative study part aiming to identify and analyze demand factors, supply factors and perceptions affecting Breast Cancer patients' treatment choices of Breast Cancer patients in 5 key decision points: participation role in the decision making process, hospital choice, treatment regimen choice, surgical extent and surgeon choice. 25 patients and caregivers will participate in the qualitative part and 425 Israeli Breast Cancer patients will participate in the quantitative study.

Background:

Breast Cancer (BC) is the most common cancer in women worldwide. Newly diagnosed BC patients are asked to participate in a number of treatment related decisions. No research has systematically studied the full decision sequence in a disease such as BC, analyzing demand factors, supply factors and patient perceptions.

Study goal:

Identify and analyze demand factors, supply factors and perceptions affecting BC patients' treatment choices, and model the demand function of BC patients in 5 key decision points: participation role in the decision making process, hospital choice, treatment regimen choice, surgical extent and surgeon choice.

Study hypothesis: Patient perceptions will have at least as much impact as demand and supply factors.

Study design:

Two stage study. A preliminary qualitative study, holding depth interviews with 20 breast cancer patients, 2 spouses and 3 staff members is taking place these days. The qualitative study findings will be used to develop a survey questionnaire for a cross sectional quantitative study, interviewing a quota sample of 425 breast cancer survivors, diagnosed up to 5 years prior to joining the study, who have successfully completed all radiation therapy and chemotherapy.

Data analysis:

Qualitative data will be analyzed according to the Criteria Bases Qualitative Methodology. Quantitative data will be analyzed by two-variable statistical analysis and multi-variable statistical analysis adjusted to the nature of the dependent and independent variables.

Possible policy recommendations:

Forming consulting teams for cancer patients. Improving medical information communication. Focusing patients on the key decisions they face. Evaluating patient needs using demand factors, supply factors and perceptions to create systemic tools helping them face treatment decisions.

Factors and Perceptions Affecting Treatment Choices of Breast Cancer Patients

Factors and Perceptions Affecting Treatment Choices of Breast Cancer Patients. Multi-center Cross-sectional Study in Israel Among Breast Cancer Survivors, With a Preliminary Qualitative Study

According to the Control Preferences Scale, a questionnaire developed by Degner and Colleagues (Degner, 1997), patients can take fully active role in the treatment decision process or be mostly active, collaborative, mostly passive or fully passive. The study will look at the factors and perceptions affecting patient's decision role.

The study interviews patients treated at two large Hospitals (Rambam, Sheba), and two small hospitals (Kaplan, Barzilay) looking for the factors and perceptions affecting large or small hospital choice.

The study will look at the factors and perceptions affecting patient's choice to undergo an oncological treatment more intense than recommended by clinical guidelines.

The study will look at the factors and perceptions affecting patient's choice to undergo a surgical cancer removal procedure more radical than recommended by clinical guidelines.

The study will look at the factors and perceptions affecting patient's choice a specific surgeon in the Israeli healthcare system.

University of Haifa

Leukemia, Myeloid, Acute

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Azacitidine

Decitabine

Guadecitabine 60 mg/m\^2 administered subcutaneously (SC) daily for 5 days (Days 1-5) in 28-day cycles.

One of the following treatment regimens: 20 mg cytarabine administered subcutaneously (SC) twice daily (BID) on Days 1-10 every 28 days; 20 mg/m\^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m\^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.

SGI-110 (guadecitabine)

Choice of one: cytarabine, decitabine, or azacitidine

To compare efficacy and safety between SGI-110 and Treatment Choice in adults with previously untreated AML who are not considered candidates for intensive remission induction chemotherapy.

SGI-110 in Adults With Untreated Acute Myeloid Leukemia (AML), Not Considered Candidates for Intensive Remission Induction

A Phase 3, Multicenter, Open-label, Randomized Study of SGI-110 Versus Treatment Choice (TC) in Adults With Previously Untreated Acute Myeloid Leukemia (AML) Who Are Not Considered Candidates for Intensive Remission Induction Chemotherapy

Number of participants with a best response of CR assessed based on International Working Group 2003 acute myeloid leukemia (AML) response criteria by a blinded independent pathologist.

Survival time was defined as the number of days from the day the participant was randomly assigned to study treatment to the date of death, regardless of cause.

CRc is reported as the number of participants with a best response of CR, complete response with incomplete platelet recovery (CRp), or complete response with incomplete blood count recovery (CRi).

The date of each hospital admission and discharge was collected for each participant for up to 6 months, unless the participant died or withdrew consent prior to that time. Duration of each hospital stay in days was calculated as date of discharge minus date of admission. The Number of Days Alive and Out of the Hospital (NDAOH) was calculated as: NDAOH=180 - total duration of all hospital stays within 180 days from the first treatment - number of death days before Day 180. For subjects who were lost to follow-up within 6 months, the NDAOH was calculated conservatively assuming that the subject would have died the day after the last contact day.

Progression-free survival was defined as the number of days from randomization to the earliest date of investigator's assessment of disease progression, participant receiving an alternative anti-leukemia therapy (including hematopoietic cell transplant), or relapse by peripheral blood (PB) assessment or blinded bone marrow (BM) assessment, whichever occurred first, or death, regardless of cause.

The total number of red blood cells (RBCs) transfused or, separately, the total number of platelets transfused up to the 6-month time point for each participant was counted from the date of randomization to Day 180, the date of last contact, or date of death, whichever occurred earlier. One RBC or platelet transfusion was defined as one unit, and a single bag of RBCs or platelets was considered one unit.

EuroQol 5-level 5-dimension (EQ-5D-5L) descriptive scores were collected for each participant for a minimum of 6 months, unless the participant died or withdrew consent. Scores within each dimension for EQ-5D (mobility, self-care, usual activity, pain/discomfort, anxiety/depression) were calculated using counts and proportions. Mean change in scores from baseline are summarized in which an index score of 0 represents the worst health state and 1 represents the best health state.

EuroQol-Visual Analogue Scale (EQ-VAS) descriptive scores were collected for each participant for a minimum of 6 months, unless the participant died or withdrew consent. A vertical 20-cm scale for EQ-VAS was used where the lowest value of 0 was labeled "the worst health you can imagine" and the top value of 100 was labeled "the best health you can imagine." Mean change in scores from baseline are summarized.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Guadecitabine (SGI-110) vs Treatment Choice in Adults With MDS or CMML Previously Treated With HMAs	NCT02907359	Myelodysplastic... Leukemia, Myelo...	Guadecitabine Treatment Choic...	18 Years -	Astex Pharmaceuticals, Inc.
BEPACT- Lung: Impact of Patient Characteristics on Pneumo-oncologists Non Small Cell Lung Cancer (NSCLC) Systemic Treatment Decision in Belgium	NCT03959137	Stage IV Non-sm...	None - Common p...	-	MSD Belgium BVBA
Factors and Perceptions Affecting Treatment Choices of Breast Cancer Patients	NCT02679638	Breast Cancer	Factors and per... Qualitative int...	30 Years - 75 Years	University of Haifa
SGI-110 in Adults With Untreated Acute Myeloid Leukemia (AML), Not Considered Candidates for Intensive Remission Induction	NCT02348489	Leukemia, Myelo...	SGI-110 (guadec... Treatment Choic...	18 Years -	Astex Pharmaceuticals, Inc.
SGI-110 in Adults With Untreated Acute Myeloid Leukemia (AML), Not Considered Candidates for Intensive Remission Induction	NCT02348489	Leukemia, Myelo...	SGI-110 (guadec... Treatment Choic...	18 Years -	Astex Pharmaceuticals, Inc.
BEPACT- Lung: Impact of Patient Characteristics on Pneumo-oncologists Non Small Cell Lung Cancer (NSCLC) Systemic Treatment Decision in Belgium	NCT03959137	Stage IV Non-sm...	None - Common p...	-	MSD Belgium BVBA
Factors and Perceptions Affecting Treatment Choices of Breast Cancer Patients	NCT02679638	Breast Cancer	Factors and per... Qualitative int...	30 Years - 75 Years	University of Haifa

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