Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Rare Diseases

Recurrence

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Dacarbazine

Interferons

Interferon-alpha

Interferon-alfa-1b

Interferon alpha-2

Fotemustine

Antiviral Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

combination chemotherapy without interferon

single agent dacarbazine without interferon

Interferon Alfa-2b

Paolo A Ascierto, M.D., Ph.D.

Antonio Daponte, M.D.

Simona Signoriello, M.D.

This study evaluated two chemotherapy regimens with and without the addition of interferon in patients with advanced or recurrent melanoma.

Fotemustine and Dacarbazine Versus Dacarbazine +/- Alpha Interferon in Advanced Malignant Melanoma

Fotemustine and Dacarbazine Versus Dacarbazine +/- Alpha Interferon in Advanced Malignant Melanoma: Phase III Study

Overall Survival was defined as the time from the date of randomisation to the date of death from any cause or the date of last follow-up for living patients.

OS curves were estimated with the Kaplan - Meier (K-M) method and treatments were compared with a two - sided log - rank test.

Progression Free Survival (PFS) was defined as the time from the date of randomisation to the date of progression of disease or death from any cause, whichever occurred first, or date of last follow-up for patients without progression and alive at the end of the study.

PFS curves were estimated with the Kaplan - Meier (K-M) method and treatments were compared with a two-sided log-rank test.

Overall Response Rate (ORR) included Complete Response (CR) and Partial Response (PR).

Complete Response (CR) was defined as disappearance of all symptoms and signs of all measurable disease, lasting for at least four weeks, without appearance of new lesions.

Partial Response (PR) was defined as a \> 50% reduction in the sum of the products of the perpendicular diameters of all measurable lesions, lasting for at least four weeks, without appearance of new lesions or enlargement of existing lesions.

worst grade CTC toxicity, for each cycle and overall, will be reported for each treatment arm

National Cancer Institute, Naples

combination chemotherapy without interferon

Fotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle

Dacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle

A1 - Combination Chemotherapy Without Interferon

combination chemotherapy with interferon

Fotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle

Dacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle

Interferon Alfa-2b: α2b 5 MUI three times per week

A2 - Combination Chemotherapy With Interferon

single agent dacarbazine without interferon

Dacarbazine: 900 mg/m2 IV on day 1 repeated on a three-week cycle

B1 - Single Agent Dacarbazine Without Interferon

single agent dacarbazine plus interferon

Dacarbazine: 900 mg / m2 every 3 weeks

Interferon Alfa-2b: α2b 5 MUI three times per week

B2 - Single Agent Dacarbazine Plus Interferon

Total

Age, Continuous

Sex: Female, Male

Italy

Region of Enrollment

Nodular melanoma

Paolo A Ascierto, M.D., Ph.D

combination chemotherapy with interferon

Fotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle

Dacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle

Interferon Alfa-2b: α2b 5 MUI three times per week

combination chemotherapy without interferon

Fotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle

Dacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle

Fotemustine/Dacarbazine/Interferon + Fotemustine/Dacarbazine

single agent dacarbazine plus interferon

Dacarbazine: 900 mg / m2 every 3 weeks

Interferon Alfa-2b: α2b 5 MUI three times per week

single agent dacarbazine without interferon

Dacarbazine: 900 mg/m2 IV on day 1 repeated on a three-week cycle

Dacarbazine/Interferon + Dacarbazine

combination chemotherapy with interferon

Fotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle

Dacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle

Interferon Alfa-2b: α2b 5 MUI three times per week

single agent dacarbazine plus interferon

Dacarbazine: 900 mg / m2 every 3 weeks

Interferon Alfa-2b: α2b 5 MUI three times per week

Fotemustine/Dacarbazine/Interferon+Dacarbazine/Interferon

combination chemotherapy without interferon

Fotemustine: 100 mg / m2 IV on day 1 repeated on a 3 week cycle

Dacarbazine: 900 mg / m2 IV on day 2 repeated on a 3 week cycle

single agent dacarbazine without interferon

Dacarbazine: 900 mg/m2 IV on day 1 repeated on a three-week cycle

Fotemustine/Dacarbazine + Dacarbazine

Nine patients were lost to follow-up immediately after randomization and, in particular, for FDI + FD 132, instead of 136 randomized (4 lost pts.), for DI + D, 128 instead of 133 (5 lost pts.), for FD1 + DI 126, instead of 131 (5 lost pts.), 134 instead of 138 (4 lost pts.)

Overall Survival (OS)

Nine patients were lost to follow-up immediately after randomization and, in particular, for FDI + FD 132, instead of 136 randomized (4 lost pts.), for DI + D, 128 instead of 133 (5 lost pts.), for FD1 + DI 126, instead of 131 (5 lost pts.), 134 instead of 138 (4 lost pts.).

Progression Free Survival (PFS)

Nine patients were lost to follow-up immediately after randomization and, in particular, for FDI + FD 132, instead of 136 randomized (4 lost pts.), for DI + D 128, instead of 133 (5 lost pts.), for FD1 + DI 126, instead of 131 (5 lost pts.), 134, instead of 138 (4 lost pts.).

Overall Response Rate (ORR)

It wasn't possible to assess the treatment related toxicity for all the patients included in the study because for some of them, no data were collected.

It's difficult to indicate the exact number of participants affected by the worst grade CTC toxicity because the same patient could be affected by one or more side effects.

Spots Global Cancer Trial Database for Fotemustine and Dacarbazine Versus Dacarbazine +/- Alpha Interferon in Advanced Malignant Melanoma

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Study Description

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