PURPOSE: Phase II trials with biochemotherapy (BCT) have shown encouraging response rates in metastatic melanoma, and meta-analyses and one phase III trial have suggested a survival benefit. In an effort to determine the relative efficacy of BCT compared with chemotherapy alone, a phase III trial was performed within the United States Intergroup. PATIENTS AND METHODS: Patients were randomly assigned to receive cisplatin, vinblastine, and dacarbazine (CVD) either alone or concurrent with interleukin-2 and interferon alfa-2b (BCT). Treatment cycles were repeated at 21-day intervals for a maximum of four cycles. Tumor response was assessed after cycles 2 and 4, then every 3 months. RESULTS:Four hundred fifteen patients were enrolled, and 395 patients (CVD, n = 195; BCT, n = 200) were deemed eligible and assessable. The two study arms were well balanced for stratification factors and other prognostic factors. Response rate was 19.5% for BCT and 13.8% for CVD (P = .140). Median progression-free survival was significantly longer for BCT than for CVD (4.8 v 2.9 months; P = .015), although this did not translate into an advantage in either median overall survival (9.0 v 8.7 months) or the percentage of patients alive at 1 year (41% v 36.9%). More patients experienced grade 3 or worse toxic events with BCT than CVD (95% v 73%; P = .001). CONCLUSION: Although BCT produced slightly higher response rates and longer median progression-free survival than CVD alone, this was not associated with either improved overall survival or durable responses. Considering the extra toxicity and complexity, this concurrent BCT regimen cannot be recommended for patients with metastatic melanoma.
RCT Entities:
PURPOSE: Phase II trials with biochemotherapy (BCT) have shown encouraging response rates in metastatic melanoma, and meta-analyses and one phase III trial have suggested a survival benefit. In an effort to determine the relative efficacy of BCT compared with chemotherapy alone, a phase III trial was performed within the United States Intergroup. PATIENTS AND METHODS: Patients were randomly assigned to receive cisplatin, vinblastine, and dacarbazine (CVD) either alone or concurrent with interleukin-2 and interferon alfa-2b (BCT). Treatment cycles were repeated at 21-day intervals for a maximum of four cycles. Tumor response was assessed after cycles 2 and 4, then every 3 months. RESULTS: Four hundred fifteen patients were enrolled, and 395 patients (CVD, n = 195; BCT, n = 200) were deemed eligible and assessable. The two study arms were well balanced for stratification factors and other prognostic factors. Response rate was 19.5% for BCT and 13.8% for CVD (P = .140). Median progression-free survival was significantly longer for BCT than for CVD (4.8 v 2.9 months; P = .015), although this did not translate into an advantage in either median overall survival (9.0 v 8.7 months) or the percentage of patients alive at 1 year (41% v 36.9%). More patients experienced grade 3 or worse toxic events with BCT than CVD (95% v 73%; P = .001). CONCLUSION: Although BCT produced slightly higher response rates and longer median progression-free survival than CVD alone, this was not associated with either improved overall survival or durable responses. Considering the extra toxicity and complexity, this concurrent BCT regimen cannot be recommended for patients with metastatic melanoma.
Authors: D F McDermott; J W Mier; D P Lawrence; M R van den Brink; M A Clancy; K M Rubin; M B Atkins Journal: Clin Cancer Res Date: 2000-06 Impact factor: 12.531
Authors: U Keilholz; S H Goey; C J Punt; T M Proebstle; R Salzmann; C Scheibenbogen; D Schadendorf; D Liénard; A Enk; R Dummer; B Hantich; A M Geueke; A M Eggermont Journal: J Clin Oncol Date: 1997-07 Impact factor: 44.544
Authors: E C Antoine; A Benhammouda; A Bernard; A Youssef; N Mortier; M Gozy; D Nizri; G Auclerc; M A Rocher; C L Soubrane; M Weil; D Khayat Journal: Cancer J Sci Am Date: 1997-12
Authors: Steven J O'Day; Peter D Boasberg; Lawrence Piro; Timothy S Kristedja; He-Jing Wang; Maureen Martin; Regina Deck; Patricia Ames; Kelly Shinn; Hannah Kim; Patricia Fournier; Guy Gammon Journal: Clin Cancer Res Date: 2002-09 Impact factor: 12.531
Authors: M B Atkins; K R O'Boyle; J A Sosman; G R Weiss; K A Margolin; M L Ernest; K Kappler; J W Mier; J A Sparano; R I Fisher Journal: J Clin Oncol Date: 1994-08 Impact factor: 44.544
Authors: Omar Eton; Sewa S Legha; Agop Y Bedikian; J Jack Lee; Antonio C Buzaid; Cynthia Hodges; Sigrid E Ring; Nicholas E Papadopoulos; Carl Plager; Mary Jo East; Feng Zhan; Robert S Benjamin Journal: J Clin Oncol Date: 2002-04-15 Impact factor: 44.544
Authors: Steven J O'Day; Michael B Atkins; Peter Boasberg; He-Jing Wang; John A Thompson; Clay M Anderson; Rene Gonzalez; Jose Lutzky; Thomas Amatruda; Evan M Hersh; Jeffrey S Weber Journal: J Clin Oncol Date: 2009-11-16 Impact factor: 44.544
Authors: Kent W Mouw; Michael S Goldberg; Panagiotis A Konstantinopoulos; Alan D D'Andrea Journal: Cancer Discov Date: 2017-06-19 Impact factor: 39.397
Authors: Enrique Espinosa; Alfonso Berrocal; José Antonio López Martín; María González Cao; Pablo Cerezuela; José Ignacio Mayordomo; Salvador Martín Algarra Journal: Clin Transl Oncol Date: 2012-05 Impact factor: 3.405
Authors: Matthew R Zeiderman; Michael E Egger; Charles W Kimbrough; Christopher G England; Tess V Dupre; Kelly M McMasters; Lacey R McNally Journal: J Surg Res Date: 2014-02-20 Impact factor: 2.192
Authors: Richard F Kefford; Philip R Clingan; Benjamin Brady; Andrea Ballmer; Adele Morganti; Peter Hersey Journal: Mol Cancer Date: 2010-03-30 Impact factor: 27.401
Authors: D Schadendorf; S M Algarra; L Bastholt; G Cinat; B Dreno; A M M Eggermont; E Espinosa; J Guo; A Hauschild; T Petrella; J Schachter; P Hersey Journal: Ann Oncol Date: 2009-08 Impact factor: 32.976