Comparison between a cisplatin‐containing regimen and a carboplatin‐containing regimen for recurrent or metastatic bladder cancer patients: A randomized phase II study

BACKGROUND The aim of this randomized Phase II study was to compare the efficacy and toxicity of a cisplatin‐containing regimen with a carboplatin‐containing regimen for patients with recurrent or metastatic bladder cancer. METHODS Fifty‐seven patients with recurrent or metastatic bladder cancer wer...

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Published in:	Cancer Vol. 77; no. 2; pp. 344 - 351
Main Authors:	Petrioli, Roberto, Frediani, Bruno, Manganelli, Antonio, Barbanti, Gabriele, De Capua, Bruno, De Lauretis, Albertina, Salvestrini, Franco, Mondillo, Sergio, Francini, Guido
Format:	Journal Article
Language:	English
Published:	New York Wiley Subscription Services, Inc., A Wiley Company 15-01-1996 Wiley-Liss
Subjects:	Aged Antineoplastic agents Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use auditory brain stem response Biological and medical sciences bladder cancer carboplatin Carboplatin - therapeutic use Chemotherapy cisplatin Cisplatin - therapeutic use Epirubicin - therapeutic use Female Humans Male Medical sciences Methotrexate - therapeutic use Middle Aged Neoplasm Metastasis Neoplasm Recurrence, Local ototoxicity Pharmacology. Drug treatments Urinary Bladder Neoplasms - drug therapy Vinblastine - therapeutic use Antineoplastic agent Human Drug combination Relapse Urinary system disease Toxicity Urinary tract disease Metastasis Malignant tumor Result Chemotherapy Treatment Urinary bladder Phase II trial Bladder disease Comparative study Platinum II Complexes
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Summary:	BACKGROUND The aim of this randomized Phase II study was to compare the efficacy and toxicity of a cisplatin‐containing regimen with a carboplatin‐containing regimen for patients with recurrent or metastatic bladder cancer. METHODS Fifty‐seven patients with recurrent or metastatic bladder cancer were randomized to receive M‐VEC treatment (methotrexate, vinblastine, epirubicin, and cisplatin) (n = 29) or M‐VECa treatment (methotrexate, vinblastine, epirubicin, and carboplatin) (n = 28). The chemotherapy was scheduled at 28‐day intervals. Recombinant granulocyte‐colony stimulating factors were administered daily when the absolute neutrophil count fell below 1000/mm3. The development of ototoxicity was evaluated by measuring auditory brain stem response. RESULTS Of the 57 entered patients, 55 were evaluable for response and toxicity. The overall clinical response rate was 71% (with 25% complete responses) in the M‐VEC group and 41% (with 11% complete responses) in the M‐VECa group (P = 0.04). M‐VEC chemotherapy was associated with more pronounced side effects. There was a statistically significant difference between M‐VEC and M‐VECa in terms of gastrointestinal toxicity (P = 0.04), nephrotoxicity (P = 0.03), and neurotoxicity (P = 0.02) during Cycle 3 of chemotherapy. Leukopenia and neutropenia were worse in the M‐VECa arm, but not significantly so (P = 0.4). Ototoxicity was only detected in one of seven examined M‐VEC patients after two cycles of chemotherapy. CONCLUSIONS M‐VECa has a low level of gastrointestinal, renal, neurologic, and otologic toxicity, but is apparently less effective than M‐VEC in the treatment of recurrent or metastatic bladder cancer. However, a larger, randomized Phase III trial is needed to confirm these results. Cancer 1996;77:344‐51.
ISSN:	0008-543X 1097-0142
DOI:	10.1002/(SICI)1097-0142(19960115)77:2<344::AID-CNCR18>3.0.CO;2-1