Neoplasms

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Adenocarcinoma

Neoplasm Metastasis

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Case with chemotherapy (Gemcitabine + nab-paclitaxel)

Nanoparticle albumin-bound paclitaxel (125 mg/m2) miv over 30 min, Day 1,8,15

Gemcitabine (1,000mg/m2) and N/S 150mL miv over 30 min, Day 1,8,15

Chemotherapy (Gemcitabine + nab-paclitaxel)

Jin Ho Choi, MD

Sang Hyub Lee, MD, Ph.D

Sang Hyub Lee, MD. PhD.

Pancreatic cancer is a very poor prognosis and has a high mortality rate. The clinical results have improved somewhat with the combination therapy of chemotherapy as the first-line treatment. However, effective secondary chemotherapy after these first-line treatment failures is limited. Recently, FOLFIRINOX has been used in patients with locally advanced or metastatic pancreatic cancer who have good performance in Korea. Gemcitabine + nab-paclitaxel (GnP) as a second-line treatment after FOLFIRINOX may be expected to be considerable. The aim of this study was to evaluate the efficacy of GnP as a second-line treatment after failed FOLFIRINOX treatment for locally advanced or metastatic pancreatic ductal adenocarcinoma.

Pancreatic cancer is a very poor prognosis and has a high mortality rate. It is not clear that the improvement of clinical outcome due to anticancer drugs is not clear compared to other carcinomas. In particular, the 5-year survival rate of metastatic pancreatic cancer is still only about 2%, and the clinical results have improved somewhat with the combination therapy of chemotherapy as the first-line treatment. However, effective secondary chemotherapy after these first-line treatment failures is limited. Meta-analysis has reported that life expectancy is significantly increased in patients receiving second-line chemotherapy after failure of primary chemotherapy. However, it is not yet clear which cancer treatment is most effective. In the NCCN guideline (ver. 2017.2), the second trial of chemotherapy for locally advanced or metastatic pancreatic cancer is the most recommended clinical trial.Recently, FOLFIRINOX has been used in patients with locally advanced or metastatic pancreatic cancer who have good performance in Korea. The response rate of the treatment is 30%, and many patients require secondary chemotherapy. In a practice guideline published by the American Society of Clinical Oncology, Gemcitabine + nab-paclitaxel(GnP) is the only recommended combination for patients failing primary treatment with FOLFIRINOX. In light of the results of previous reports, the efficacy of GnP as a second-line treatment after FOLFIRINOX may be expected to be considerable, but there is a lack of studies reporting GnP therapy on the second line after FOLFIRINOX failure as a first-line treatment. The aim of this study was to evaluate the efficacy of GnP as a second-line treatment after failed FOLFIRINOX treatment for locally advanced or metastatic pancreatic ductal adenocarcinoma.

The Effect of Gemcitabine Plus Nab-paclitaxel as Secondary Chemotherapy in Advanced Pancreatic Cancer

survival rate at 6 months after 2nd line chemotherapy

overall survival after 2nd line chemotherapy

duration till progression after 2nd line chemotherapy

SD (stable disease) + PR (partial response) + CR (complete response) after 2nd line chemotherapy

all reported adverse events after 2nd line chemotherapy

Seoul National University Hospital

Professor

Stomach Neoplasms

Stomach Diseases

Stomach Cancer

Irinotecan

Topoisomerase I Inhibitors

Enzyme Inhibitors

Irinotecan 150mg/m2 iv on day one and S-1 po days 1 to 14 every 3 weeks until PD

S-1 + irinotecan

Irinotecan 150mg/m2 iv on day one every two weeks until PD

irinotecan

Masashi Fujii, M.D.,PhD

The purpose of this study is compare overall survival of the test arm (CPT-11/S-1 combination) to the control arm (CPT-11 alone) in the subjects with S-1 refractory advanced gastric cancer.

Standard chemotherapy for advanced gastric cancer (AGC) in the US is Cisplatin/5-FU (CF) or docetaxel/CF (DCF), is in Europe epirubicin/CF (ECF) or epirubicin/oxaliplatin/ capecitabine (EOX). Until 2006, there was no evidence of standard chemotherapy for AGC in Japan. In 2007, by the results of JCOG9912 trial (5-FU alone vs. CPT-11/CDDP vs S-1) and SPIRITS trial (S-1 alone vs. S-1/CDDP), S-1/CDDP is regarded as a new standard regimen in Japan. In 2008, by the results of TOP-002 trial (s-1 alone vs. S-1/CPT-11), S-1/CPT-11 could not show the superiority to S-1 alone. One of the other phase III trials, JACCRO GC-03 trial (S-1 alone vs. S-1/docetaxel, NCT00287768) is now ongoing. However, the position of CPT-11 in the treatment of AGC will be regarded as a second-line.

In Japan there is a controversy for the treatment of S-1 refractory gastric cancer. The controversy is continuing S-1 (like FOLFOX to FOLFIRI) or not as a second-line. After the successful adjuvant S-1 results (ACTS-GC trial), the same problem will occur in the patients who are recurrent from adjuvant S-1.

Then, we conducted a phase II/III trial of CPT-11 with or without S-1 in the treatment of first-line S-1 refractory AGC.

Second Line Chemotherapy for S-1 Refractory Advanced Gastric Cancer

Randomized Phase II/III Trial of Second Line Chemotherapy Comparing CPT-11 Monotherapy Versus S-1/CPT-11 Combination for S-1 Refractory Gastric Cancer

Taiho Pharmaceutical Co., Ltd.

Japan Clinical Cancer Research Organization

Masashi Fujii/Associate Professor

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Neoplasms, Squamous Cell

Amino Acids

Pembrolizumab

Immunomodulating Agents

Afatinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Tyrosine

Second line (2L) afatinib treated following discontinuation of pembrolizumab in combination with platinum-based doublet chemotherapy (first line (1L))

Second line (2L) chemotherapy treated following discontinuation of pembrolizumab in combination with platinum-based doublet chemotherapy (first line (1L))

Second line (2L) afatinib

Second line chemotherapy

This study aims to characterize the profile and outcomes for patients with Squamous Cell Carcinoma of the Lung (SqCC) who progress on 1L pembrolizumab in combination with platinum based chemotherapy and receive afatinib as second line (2L) therapy.

A Study in the United States Using Electronic Medical Records (EMR) to Assess Effectiveness of Afatinib (Gilotrif) Following Pembrolizumab and Chemotherapy in the Treatment of Metastatic Squamous Cell Carcinoma of the Lung

Real-World Effectiveness of Afatinib (Gilotrif) Following Immunotherapy in the Treatment of Metastatic, Squamous Cell Carcinoma of the Lung: A Multi-Site Retrospective Chart Review Study in the U.S.

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to:

https://www.mystudywindow.com/msw/datatransparency

Time on treatment was defined as the interval from the start of second-line treatment until discontinuation of second-line treatment for any reason, e.g. toxicity, progression, death, patient choice. The end of 2L treatment was defined as the date of last treatment order for afatinib plus the days of supply on the last known treatment order up to the date of data collection (but not exceeding). The Kaplan-Meier (KM) method was used to estimate the median and 95% confidence interval for time on treatment.

Time on treatment was defined as the interval from the start of second-line treatment until discontinuation of second-line treatment for any reason, e.g. toxicity, progression, death, patient choice. The end of 2L treatment was defined as the date of last treatment order for afatinib plus the days of supply on the last known treatment order up to the date of data collection (but not exceeding). The Kaplan-Meier (KM) method was used to estimate the median and 95% confidence interval for time on treatment. Patients treated with afatinib were analysed for their histology status and categorized into a squamous cell - or mixed histology treatment group.

Chart abstractors (i.e. the patients treating physician) were asked to abstract information regarding severe (grade 3 or higher) irAEs of specific interest (including pneumonitis, colitis, hepatitis, interstitial lung disease, higher indeterminate pulmonary events, death, or discontinuation of therapy due to toxicity) during first line (1L) treatment and second line (2L) for both patients treated with afatinib in 2L and those treated with chemotherapy in 2L. Providers/abstractors were asked only if these specific immune related events occurred.

Boehringer Ingelheim

Adverse events (AEs) were only collected and reported for 2L afatinib treatment group according to protocol requirements.

All 2L afatinib treatment group patients (pts) who initiated first-line (1L) pembrolizumab and platinum-based combination chemotherapy (CT) after 1st June 2018, and subsequently discontinued 1L therapy and had started second-line (2L) treatment with afatinib at least 3 months prior to date of data collection.

Serious AEs were not collected and reported for this study.

Patients in the second-line afatinib treatment group initiated first-line pembrolizumab and platinum-based combination chemotherapy after 1st June 2018, and subsequently discontinued first-line therapy. All patients had started second-line treatment with afatinib at least 3 months prior to the date of data collection.

Second-line Afatinib Treatment Group

Patients in the second-line chemotherapy treatment group initiated first-line pembrolizumab and platinum-based combination chemotherapy after 1st June 2018, and subsequently discontinued first-line therapy. All patients had started second-line treatment with any chemotherapy at least 3 months prior to the date of data collection.

Second-line Chemotherapy Treatment Group

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Squamous cell only

Mixed histology

Tumor histology

EGFR mutation positive

EGFR mutation negative

Not tested / unknown

Epidermal growth factor receptor (EGFR) mutation status

Never smoked

Current smoker

Former smoker

Smoking history

ECOG 0/1

ECOG ≥ 2

Eastern Cooperative Oncology Group Performance Status (ECOG PS) is used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis. 0 = Fully Active (Most Favorable Activity); 1 = Restricted activity but ambulatory; 2 = Ambulatory but unable to carry out work activities; 3 = Limited Self-Care; 4 = Completely Disabled, No self-care (Least Favorable Activity)

Eastern Cooperative Oncology Group Performance Status at initiation of second line (2L) treatment

Tumor stage I to IIIA

Tumor stage IIIB

Tumor stage IV

Disease stage means how big tumor is + how far it has spread. They range from 0 (not spread) to IV (spread throughout body). 0 - cancer not spread beyond inner lining of affected organ; I - is small and not spread to lymph nodes (LN); II - spread to some LN near original tumor; III - spread to nearby tissue or spread to far away LN (IIIA: heterogeneous group with diversity of tumor characteristics and varying degrees of LN involvement; IIIB: involves LN on opposite side of chest or above collar bone, or heart or trachea + LN in chest center or near windpipe); IV - has spread to other organs.

Tumor stage at initial diagnosis

Liver

Contralateral lung nodule

Blood and bone marrow

Adrenal gland

Pleura (nodules, effusion)

Intra-abdominal lymph nodes

Brain

Sites of metastatic disease at initiation of second line treatment

Any comorbidity

Hypertension

Chronic pulmonary disease

Cardiovascular disease

Depression

Diabetes without chronic complications

Most common comorbidities at initiation of second line treatment

First line or prior

Second line

Radiation therapy

1 to 49%

>50%

Not tested

Programmed death ligand 1 (PD-L1) expression level

All patients (pts) aged ≥18 years, initiated first-line (1L) pembrolizumab and platinum-based combination chemotherapy (CT) after 1st June 2018, and subsequently discontinued 1L therapy. All pts had started second-line treatment with either afatinib or any CT at least 3 months prior to date of data collection. Maximum follow-up for any pts was approx 15 months. Pts were excluded if they had received pembrolizumab in combination with platinum-based CT as part of an interventional clinical trial.

Boehringer Ingelheim, Call Centre

All patients (pts) who initiated first-line (1L) pembrolizumab and platinum-based combination chemotherapy (CT) after 1st June 2018, and subsequently discontinued 1L therapy and had started second-line treatment with either afatinib or any CT at least 3 months prior to date of data collection.

Time on Treatment With Afatinib or Chemotherapy During Second Line (2L) Treatment

Patients in the second-line afatinib treatment group with squamous cell histology initiated first-line pembrolizumab and platinum-based combination chemotherapy after 1st June 2018, and subsequently discontinued first-line therapy. All patients with squamous cell histology had started second-line treatment with afatinib at least 3 months prior to the date of data collection.

Second-line Afatinib Treatment Group With Squamous Cell Histology

Patients in the second-line afatinib treatment group with mixed histology initiated first-line pembrolizumab and platinum-based combination chemotherapy after 1st June 2018, and subsequently discontinued first-line therapy. All patients with mixed histology had started second-line treatment with afatinib at least 3 months prior to the date of data collection.

Second-line Afatinib Treatment Group With Mixed Histology

All patients (pts) who initiated first-line (1L) pembrolizumab and platinum-based combination chemotherapy (CT) after 1st June 2018, and subsequently discontinued 1L therapy and had started second-line treatment with afatinib at least 3 months prior to date of data collection. Only patients treated with afatinib and with squamous cell - or mixed histology were included in the analysis.

Time on Treatment With Afatinib During Second Line (2L) Treatment Defined by Histology Status

Patients in the second-line afatinib treatment group with EGFR mutation positive status initiated first-line pembrolizumab and platinum-based combination chemotherapy after 1st June 2018, and subsequently discontinued first-line therapy. All patients with EGFR mutation positive status had started second-line treatment with afatinib at least 3 months prior to the date of data collection.

Second-line Afatinib Treatment Group With Epidermal Growth Factor Receptor Mutation Positive Status

Patients in the second-line afatinib treatment group with Epidermal growth factor receptor (EGFR) mutation negative status initiated first-line pembrolizumab and platinum-based combination chemotherapy after 1st June 2018, and subsequently discontinued first-line therapy. All patients with EGFR mutation negative status had started second-line treatment with afatinib at least 3 months prior to the date of data collection.

Second-line Afatinib Treatment Group With Epidermal Growth Factor Receptor Mutation Negative Status

All patients (pts) who initiated first-line (1L) pembrolizumab and platinum-based combination chemotherapy (CT) after 1st June 2018, and subsequently discontinued 1L therapy and had started second-line treatment with afatinib at least 3 months prior to date of data collection. Only afatinib treated patients with an EGFR mutation positive or negative status were included in the analysis.

Time on Treatment With Afatinib During Second Line (2L) Treatment Defined by Epidermal Growth Factor Receptor (EGFR) Mutation Status

Number of Patients With Severe Immune-related Adverse Events (irAEs) of Specific Interest During Second-line Treatment

Overall Study

Recurrence

Small Cell Lung Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Topotecan

Vorinostat

Histone Deacetylase Inhibitors

Vorinostat/topotecan dose escalation regimen. vorinostat is administered orally once a day for 7 to 14 consecutive days, according to the dose level.Topotecan is administered I.V. for 5 consecutive days every three weeks.

Vorinostat dose levels go from 300 mg/day for 7 days to 400 mg/day for 14 days. Topotecan dose levels go from 1,2 mg/m2 to 1,5 mg/m2

Phase I study: vorinostat will be administered daily for a number of days per cycle variable from 7 to 14 according to the level of dose escalation; topotecan will be administered I.V. for 5 consecutive days every 3 weeks.

Phase II study: Patients will receive treatment at the recommended dose established by phase I part of the trial, for a maximum of 6 cycles or until disease progression, unacceptable toxicity or patient's refusal.

topotecan, vorinostat

Armando Santoro, MD

The purpose of this study is to evaluate the maximum tolerated dose, the activity and the safety profile of the combination of vorinostat and topotecan in patients with recurrent small cell lung cancer

Study of Oral Vorinostat in Combination With Topotecan in Patients With Chemosensitive Recurrent SCLC

Phase I-II Study of Oral Suberoylanilide Hydroxamic Acid (Vorinostat) in Combination With Topotecan in Patients With Chemosensitive Recurrent Small Cell Lung Cancer (SCLC)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Effect of Gemcitabine Plus Nab-paclitaxel as Secondary Chemotherapy in Advanced Pancreatic Cancer	NCT03401827	Pancreatic Aden... Chemotherapy Ef...	Chemotherapy (G...	20 Years -	Seoul National University Hospital
Second Line Chemotherapy for S-1 Refractory Advanced Gastric Cancer	NCT00639327	Gastric Cancer	S-1 + irinoteca... irinotecan	20 Years -	Japan Clinical Cancer Research Organization
A Study in the United States Using Electronic Medical Records (EMR) to Assess Effectiveness of Afatinib (Gilotrif) Following Pembrolizumab and Chemotherapy in the Treatment of Metastatic Squamous Cell Carcinoma of the Lung	NCT04552535	Squamous Non-sm...	Second line (2L... Second line che...	18 Years -	Boehringer Ingelheim
Study of Oral Vorinostat in Combination With Topotecan in Patients With Chemosensitive Recurrent SCLC	NCT00697476	Small Cell Lung...	topotecan, vori...	18 Years -	Istituto Clinico Humanitas
A Study in the United States Using Electronic Medical Records (EMR) to Assess Effectiveness of Afatinib (Gilotrif) Following Pembrolizumab and Chemotherapy in the Treatment of Metastatic Squamous Cell Carcinoma of the Lung	NCT04552535	Squamous Non-sm...	Second line (2L... Second line che...	18 Years -	Boehringer Ingelheim

Spots Global Cancer Trial Database for second line chemotherapy