Cisplatin and Dacarbazine With or Without Subcutaneous Interleukin-2 and Interferon Alfa-2b in Advanced Melanoma Outpatients
Authors: Jhansi Koduri, Michael A. Baumann, Ruggero Ridolfi, Oriana Nanni
Journal: Journal of Clinical Oncology (2002)

Article Tools SPECIAL DEPARTMENTS Article Tools OPTIONS & TOOLS Export Citation Track Citation Add To Favorites Rights & Permissions COMPANION ARTICLES No companion articles ARTICLE CITATION DOI: 10.1200/JCO.2002.99.202 Journal of Clinical Oncology - published online before print September 21, 2016 PMID: 12177119 Cisplatin and Dacarbazine With or Without Subcutaneous Interleukin-2 and Interferon Alfa-2b in Advanced Melanoma Outpatients Jhansi KodurixJhansi KoduriSearch for articles by this author , Michael A. BaumannxMichael A. BaumannSearch for articles by this author Ruggero RidolfixRuggero RidolfiSearch for articles by this author , Oriana NannixOriana NanniSearch for articles by this author , Show More Wright State University School of Medicine, Dayton, OHPierantoni HospitalIstituto Oncologico Romagnolo, Forlì, Italy https://doi.org/10.1200/JCO.2002.99.202 First Page Full Text PDF Figures and Tables © 2002 by American Society of Clinical OncologyjcoJ Clin OncolJournal of Clinical OncologyJCO0732-183X1527-7755American Society of Clinical OncologyResponse15082002In Reply:There has undoubtedly been a trend in recent years in the literature showing that combined chemoimmunotherapeutic drugs improve the survival of patients with advanced melanoma. The overall survival (OS) of patients with advanced melanoma passed from 6 to 9 months in Lotze et al’s1 description to more than 11 months with chemoimmunotherapeutic treatments, as is highlighted in the meta-analysis by Keilholz et al2 and Allen et al3 conducted on a very large number of patients.The study by Eton et al,4 presented at the Thirty-Sixth Annual Meeting of the American Society of Clinical Oncology in 2000, seemed to indicate, for the first time, a significant difference in terms of OS between chemotherapy (9.5 months) and biochemotherapy (11.8 months). The definitive study recently published confirmed these data, albeit with borderline statistical significance.5 However, this study required a recruitment of more than 7 years because of the complexity of the treatment scheme, which had a marked toxicity.The results of our work are in line with this tendency, reporting an OS of 9.5 months for the chemotherapy-only arm versus 11 months for the biochemotherapy arm, albeit not reaching statistical significance. Therefore, we believe that we were correct in sustaining that our results “do not differ greatly from the best results with high-dose IL-2-containing regimens reported in the literature”.6Furthermore, we would like to point out that recruitment for our study was completed in less than 3 years and that therapy was administered in an out-patient setting and was well-tolerated. This therapy is therefore feasible in a large majority of patients with advanced melanoma who are less numerous than those with other cancer pathologies in which it is easier to conduct higher powered studies.With regard to quality-of-life (QOL) assessment, the preliminary data of which were presented at the Thirty-Seventh Annual Meeting of the American Society of Clinical Oncology in 2001,7 a paper comprising definitive results was recently submitted for publication. Briefly, we prospectively studied baseline QOL using the Rotterdam Symptom Checklist before and after each cycle in 80% of the 176 randomized patients. We found that the QOL decreased in both chemotherapy and biochemotherapy patients with respect to baseline in all domains (Overall Global Life Quality, Activity Level, Physical Symptom Distress, and Psychological Distress) and was slightly worse in the biochemotherapy-treated group, with no significant differences between the two arms.1. Lotze MT, Dallal RM, Kirkwood JM, et al: Cutaneous melanoma, in De Vita VT, Hellman S, Rosenberg SA (eds): Cancer, Principles and Practice of Oncology, ed 6. Philadelphia, PA, Lippincott Williams & Wilkins, pp 2012,2001,-2069 Google Scholar2. Keilholz U, Conradt C, Legha SS, et al: Results of interleukin-2-based treatment in advanced melanoma: A case record-base analysis of 631 patients. J Clin Oncol 16:: 2921,1998-2929, Link, Google Scholar3. Allen IE, Kupelnick B, Kumashiro M: Efficacy of interleukin-2 in the treatment of metastatic melanoma-systemic review and metastasis-analysis. Cancer Therapeutics 1:: 168,1998-173, Google Scholar4. Eton O, Legha S, Bedikian A, et al: Phase III randomized trial of cisplatin, vinblastine and dacarbazine (CVD) plus interleukin-2 (IL-2) and interferon-alpha-2b (IFN) versus CVD in patients (Pts) with metastatic melanoma. Proc Am Soc Clin Oncol 19:: 552a,,2000 (abstr 2174) Google Scholar5. Eton O, Legha SS, Bedikian AY, et al: Sequential biochemotherapy versus chemotherapy for metastatic melanoma: Results from a phase III randomized trial. J Clin Oncol 20:: 2045,2002-2052, Link, Google Scholar6. Ridolfi R, Chiaron-Sileni V, Guida M, et al: Cisplatin, dacarbazine with or without subcutaneous interleukin-2 and interferon alfa-2b in advanced melanoma outpatients: Results from an Italian multicenter phase III randomized clinical trial. J Clin Oncol 20:: 1600,2002-1607, Link, Google Scholar7. Chiaron-Sileni V, Lo Presti G, Chiara A, et al: Quality of life (QoL) evaluation in randomized trials of chemotherapy (CT) vs biochemotherapy (BioCT) in advanced melanoma (AM). Proc Am Soc Clin Oncol 20:: 352a,,2001 (abstr 1404) Google Scholar