Fotemustine compared with dacarbazine in patients with disseminated malignant melanoma

A phase III study

Marie Françoise Avril, S. Aamdal, J. J. Grob, A. Hauschild, P. Mohr, J. J. Bonerandi, M. Weichenthal, K. Neuber, T. Bieber, K. Gilde, V. Guillem Porta, J. Fra, J. Bonneterre, P. Saïag, D. Kamanabrou, H. Pehamberger, J. Sufliarsky, J. L Gonzalez Larriba, A. Scherrer, Y. Menu

Research output: Contribution to journalArticle

375 Citations (Scopus)

Abstract

Purpose: To compare fotemustine and dacarbazine (DTIC) in terms of overall response rate (ORR) as primary end-point and overall survival, duration of responses, time to progression, time to occurrence of brain metastases (BM), and to assess safety and quality of life in patients with disseminated cutaneous melanoma. Patients and Methods: Patients received either intravenous fotemustine 100 mg/m2 weekly for 3 weeks or DTIC 250 mg/m2/d for 5 consecutive days every 4 weeks (two cycles). Nonprogressive patients received a maintenance treatment every 4 weeks (fotemustine 100 mg/m2 or DTIC 250 mg/m2 for 5 days). Results: Two hundred twenty-nine patients were randomly assigned to fotemustine or DTIC arms. The best ORR was higher in the fotemustine arm than in the DTIC arm in the intent-to-treat population (n = 229; 15.2% v 6.8%; P = .043) and in full analysis set (n = 221) (15.5% v 7.2%; P = .053). Similar median durations of responses (5.8 months with fotemustine v 6.9 months with DTIC) and time to progression (1.8 v 1.9 months, respectively) were observed. In patients without BM at inclusion, the median time to BM was 22.7 months with fotemustine versus 7.2 months with DTIC (P = .059). Median survival was 7.3 months with fotemustine versus 5.6 months with DTIC (P = .067). The main toxicity was grade 3 to 4 neutropenia (51% with fotemustine v 5% with DTIC) and thrombocytopenia (43% v 6%, respectively). No significant difference was noted for quality of life between arms. Conclusion: ORR was higher in the fotemustine arm compared to the DTIC arm in first-line treatment of disseminated melanoma. A trend in favor of fotemustine in terms of overall survival and time to BM was evidenced.

Original languageEnglish
Pages (from-to)1118-1125
Number of pages8
JournalJournal of Clinical Oncology
Volume22
Issue number6
DOIs
Publication statusPublished - 2004

Fingerprint

fotemustine
Dacarbazine
Melanoma
Neoplasm Metastasis
Brain
Survival
Quality of Life

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Avril, M. F., Aamdal, S., Grob, J. J., Hauschild, A., Mohr, P., Bonerandi, J. J., ... Menu, Y. (2004). Fotemustine compared with dacarbazine in patients with disseminated malignant melanoma: A phase III study. Journal of Clinical Oncology, 22(6), 1118-1125. https://doi.org/10.1200/JCO.2004.04.165

Fotemustine compared with dacarbazine in patients with disseminated malignant melanoma : A phase III study. / Avril, Marie Françoise; Aamdal, S.; Grob, J. J.; Hauschild, A.; Mohr, P.; Bonerandi, J. J.; Weichenthal, M.; Neuber, K.; Bieber, T.; Gilde, K.; Porta, V. Guillem; Fra, J.; Bonneterre, J.; Saïag, P.; Kamanabrou, D.; Pehamberger, H.; Sufliarsky, J.; Larriba, J. L Gonzalez; Scherrer, A.; Menu, Y.

In: Journal of Clinical Oncology, Vol. 22, No. 6, 2004, p. 1118-1125.

Research output: Contribution to journalArticle

Avril, MF, Aamdal, S, Grob, JJ, Hauschild, A, Mohr, P, Bonerandi, JJ, Weichenthal, M, Neuber, K, Bieber, T, Gilde, K, Porta, VG, Fra, J, Bonneterre, J, Saïag, P, Kamanabrou, D, Pehamberger, H, Sufliarsky, J, Larriba, JLG, Scherrer, A & Menu, Y 2004, 'Fotemustine compared with dacarbazine in patients with disseminated malignant melanoma: A phase III study', Journal of Clinical Oncology, vol. 22, no. 6, pp. 1118-1125. https://doi.org/10.1200/JCO.2004.04.165
Avril, Marie Françoise ; Aamdal, S. ; Grob, J. J. ; Hauschild, A. ; Mohr, P. ; Bonerandi, J. J. ; Weichenthal, M. ; Neuber, K. ; Bieber, T. ; Gilde, K. ; Porta, V. Guillem ; Fra, J. ; Bonneterre, J. ; Saïag, P. ; Kamanabrou, D. ; Pehamberger, H. ; Sufliarsky, J. ; Larriba, J. L Gonzalez ; Scherrer, A. ; Menu, Y. / Fotemustine compared with dacarbazine in patients with disseminated malignant melanoma : A phase III study. In: Journal of Clinical Oncology. 2004 ; Vol. 22, No. 6. pp. 1118-1125.
@article{469037f5fb254793b35d5d1f64b9e92e,
title = "Fotemustine compared with dacarbazine in patients with disseminated malignant melanoma: A phase III study",
abstract = "Purpose: To compare fotemustine and dacarbazine (DTIC) in terms of overall response rate (ORR) as primary end-point and overall survival, duration of responses, time to progression, time to occurrence of brain metastases (BM), and to assess safety and quality of life in patients with disseminated cutaneous melanoma. Patients and Methods: Patients received either intravenous fotemustine 100 mg/m2 weekly for 3 weeks or DTIC 250 mg/m2/d for 5 consecutive days every 4 weeks (two cycles). Nonprogressive patients received a maintenance treatment every 4 weeks (fotemustine 100 mg/m2 or DTIC 250 mg/m2 for 5 days). Results: Two hundred twenty-nine patients were randomly assigned to fotemustine or DTIC arms. The best ORR was higher in the fotemustine arm than in the DTIC arm in the intent-to-treat population (n = 229; 15.2{\%} v 6.8{\%}; P = .043) and in full analysis set (n = 221) (15.5{\%} v 7.2{\%}; P = .053). Similar median durations of responses (5.8 months with fotemustine v 6.9 months with DTIC) and time to progression (1.8 v 1.9 months, respectively) were observed. In patients without BM at inclusion, the median time to BM was 22.7 months with fotemustine versus 7.2 months with DTIC (P = .059). Median survival was 7.3 months with fotemustine versus 5.6 months with DTIC (P = .067). The main toxicity was grade 3 to 4 neutropenia (51{\%} with fotemustine v 5{\%} with DTIC) and thrombocytopenia (43{\%} v 6{\%}, respectively). No significant difference was noted for quality of life between arms. Conclusion: ORR was higher in the fotemustine arm compared to the DTIC arm in first-line treatment of disseminated melanoma. A trend in favor of fotemustine in terms of overall survival and time to BM was evidenced.",
author = "Avril, {Marie Fran{\cc}oise} and S. Aamdal and Grob, {J. J.} and A. Hauschild and P. Mohr and Bonerandi, {J. J.} and M. Weichenthal and K. Neuber and T. Bieber and K. Gilde and Porta, {V. Guillem} and J. Fra and J. Bonneterre and P. Sa{\"i}ag and D. Kamanabrou and H. Pehamberger and J. Sufliarsky and Larriba, {J. L Gonzalez} and A. Scherrer and Y. Menu",
year = "2004",
doi = "10.1200/JCO.2004.04.165",
language = "English",
volume = "22",
pages = "1118--1125",
journal = "Journal of Clinical Oncology",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",
number = "6",

}

TY - JOUR

T1 - Fotemustine compared with dacarbazine in patients with disseminated malignant melanoma

T2 - A phase III study

AU - Avril, Marie Françoise

AU - Aamdal, S.

AU - Grob, J. J.

AU - Hauschild, A.

AU - Mohr, P.

AU - Bonerandi, J. J.

AU - Weichenthal, M.

AU - Neuber, K.

AU - Bieber, T.

AU - Gilde, K.

AU - Porta, V. Guillem

AU - Fra, J.

AU - Bonneterre, J.

AU - Saïag, P.

AU - Kamanabrou, D.

AU - Pehamberger, H.

AU - Sufliarsky, J.

AU - Larriba, J. L Gonzalez

AU - Scherrer, A.

AU - Menu, Y.

PY - 2004

Y1 - 2004

N2 - Purpose: To compare fotemustine and dacarbazine (DTIC) in terms of overall response rate (ORR) as primary end-point and overall survival, duration of responses, time to progression, time to occurrence of brain metastases (BM), and to assess safety and quality of life in patients with disseminated cutaneous melanoma. Patients and Methods: Patients received either intravenous fotemustine 100 mg/m2 weekly for 3 weeks or DTIC 250 mg/m2/d for 5 consecutive days every 4 weeks (two cycles). Nonprogressive patients received a maintenance treatment every 4 weeks (fotemustine 100 mg/m2 or DTIC 250 mg/m2 for 5 days). Results: Two hundred twenty-nine patients were randomly assigned to fotemustine or DTIC arms. The best ORR was higher in the fotemustine arm than in the DTIC arm in the intent-to-treat population (n = 229; 15.2% v 6.8%; P = .043) and in full analysis set (n = 221) (15.5% v 7.2%; P = .053). Similar median durations of responses (5.8 months with fotemustine v 6.9 months with DTIC) and time to progression (1.8 v 1.9 months, respectively) were observed. In patients without BM at inclusion, the median time to BM was 22.7 months with fotemustine versus 7.2 months with DTIC (P = .059). Median survival was 7.3 months with fotemustine versus 5.6 months with DTIC (P = .067). The main toxicity was grade 3 to 4 neutropenia (51% with fotemustine v 5% with DTIC) and thrombocytopenia (43% v 6%, respectively). No significant difference was noted for quality of life between arms. Conclusion: ORR was higher in the fotemustine arm compared to the DTIC arm in first-line treatment of disseminated melanoma. A trend in favor of fotemustine in terms of overall survival and time to BM was evidenced.

AB - Purpose: To compare fotemustine and dacarbazine (DTIC) in terms of overall response rate (ORR) as primary end-point and overall survival, duration of responses, time to progression, time to occurrence of brain metastases (BM), and to assess safety and quality of life in patients with disseminated cutaneous melanoma. Patients and Methods: Patients received either intravenous fotemustine 100 mg/m2 weekly for 3 weeks or DTIC 250 mg/m2/d for 5 consecutive days every 4 weeks (two cycles). Nonprogressive patients received a maintenance treatment every 4 weeks (fotemustine 100 mg/m2 or DTIC 250 mg/m2 for 5 days). Results: Two hundred twenty-nine patients were randomly assigned to fotemustine or DTIC arms. The best ORR was higher in the fotemustine arm than in the DTIC arm in the intent-to-treat population (n = 229; 15.2% v 6.8%; P = .043) and in full analysis set (n = 221) (15.5% v 7.2%; P = .053). Similar median durations of responses (5.8 months with fotemustine v 6.9 months with DTIC) and time to progression (1.8 v 1.9 months, respectively) were observed. In patients without BM at inclusion, the median time to BM was 22.7 months with fotemustine versus 7.2 months with DTIC (P = .059). Median survival was 7.3 months with fotemustine versus 5.6 months with DTIC (P = .067). The main toxicity was grade 3 to 4 neutropenia (51% with fotemustine v 5% with DTIC) and thrombocytopenia (43% v 6%, respectively). No significant difference was noted for quality of life between arms. Conclusion: ORR was higher in the fotemustine arm compared to the DTIC arm in first-line treatment of disseminated melanoma. A trend in favor of fotemustine in terms of overall survival and time to BM was evidenced.

UR - http://www.scopus.com/inward/record.url?scp=1842562211&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=1842562211&partnerID=8YFLogxK

U2 - 10.1200/JCO.2004.04.165

DO - 10.1200/JCO.2004.04.165

M3 - Article

VL - 22

SP - 1118

EP - 1125

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

SN - 0732-183X

IS - 6

ER -