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      Carboplatin-Gemcitabine Treatment of Patients with Transitional Cell Carcinoma of the Bladder and Impaired Renal Function

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          Abstract

          Introduction: Bladder cancer is a frequently occurring tumour in Spain and usually affects elderly patients with renal impairment. The development of new combination therapies for such patients is thus of vital importance. Patients and Methods: Between 1997 and 1998, 17 patients with locally advanced non-surgical or metastatic bladder tumours were treated at our centres. Treatment consisted of 1,000 mg/m<sup>2</sup> of gemcitabine administered on days 1 and 8, and carboplatin (area under the concentration curve = 5) on day 1, every 21 days. Results: The mean age of the patients [4 females (26%) and 13 males] was 69 years (range: 54–78 years). The average Karnofsky performance status was 80% (range: 50–100%). Mean creatinine clearance was 45.4 ml/min (range: 21–55 ml/min). There were 2 complete responses, 7 partial responses (RO: 56%; range 31–81%), 6 patients had stable disease and 1 disease progression. Haematological toxicities were as follows: grade I anaemia in 2 patients, grade III in 3; grade I granulocytopenia in 2 patients, grade III–IV in 4 patients; grade III thrombocytopenia in 3 patients. Toxic death occurred in the course of one grade IV neutropenic event. Non-haematological toxicities were as follows: grade I–II vomiting in 3 patients and grade III in 1. One patient had grade III hepatic toxicity. One patient had grade III renal toxicity, and 3 patients grade II alopecia. Conclusions: The above-mentioned treatment has low toxicity, is easy to administer and offers promising results in this group of patients.

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          Carboplatin-based versus cisplatin-based chemotherapy in the treatment of surgically incurable advanced bladder carcinoma.

          The carboplatin-based chemotherapeutic regimen M-CAVI (methotrexate, carboplatin, and vinblastine) is active against bladder carcinoma and can be administered to patients who are ineligible to receive cisplatin or doxorubicin. The authors designed a randomized study to evaluate whether M-CAVI offers a therapeutic advantage over the cisplatin-based regimen M-VAC (methotrexate, vinblastine, doxorubicin, and cisplatin) in the treatment of patients with surgically incurable advanced bladder carcinoma. Patients with surgically incurable advanced bladder carcinoma were enrolled on a randomized trial comparing M-CAVI, which consists of carboplatin (300 mg/m2 on Day 2, adjusted using Calvert's formula for an area under the curve of 5), methotrexate (30 mg/m2 on Days 1, 15, and 22), and vinblastine (3 mg/m2 on Days 2, 15, and 22) administered every 28 days, versus standard M-VAC. The eligibility criteria included histologically proven bladder carcinoma, surgically incurable disease, and no prior chemotherapy. Patients were treated until disease progression or unacceptable toxicity occurred. From January 1989 to January 1994, 47 assessable patients were included. Seventeen patients had lymph node disease and 30 had distant metastatic disease. Twenty-three patients were randomized to receive M-CAVI and 24 to receive M-VAC. Patient characteristics in the two groups were similar. Overall response rates were 39% (95% confidence interval [CI], 20-62%) for M-CAVI and 52% (95% CI, 30-73%) for M-VAC (P = 0.3), with 3 complete responses observed among patients treated with M-VAC and none among those in the M-CAVI group. M-VAC was associated with more gastrointestinal toxicity, stomatitis, alopecia, and Grade 4 neutropenia than M-CAVI. One toxicity-related death occurred in the M-VAC group. There was a statistically significant difference in median disease-related survival time favoring M-VAC (16 months; range, 6 to 22+) versus M-CAVI (9 months; range, 6 to 14+) (P = 0.03). M-CAVI is less toxic but less active than M-VAC in the treatment of patients with advanced bladder carcinoma. Carboplatin-based regimens in which carboplatin is administered at the dose range used in the current study should be reserved for patients who cannot tolerate cisplatin treatment. Further research is required to assess the impact of high dose carboplatin in the treatment of this disease.
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            Comparison between a cisplatin-containing regimen and a carboplatin-containing regimen for recurrent or metastatic bladder cancer patients. A randomized phase II study.

            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. 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. 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. 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.
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              Author and article information

              Journal
              OCL
              Oncology
              10.1159/issn.0030-2414
              Oncology
              S. Karger AG
              0030-2414
              1423-0232
              2000
              June 2000
              30 June 2000
              : 59
              : 1
              : 24-27
              Affiliations
              Oncology Units, aHospital del Mar-IMIM, Universitat Autònoma de Barcelona, bConsorci Hospitalari Parc Taulí, Sabadell, and cCentre Cardiologic de Manresa, Spain
              Article
              12132 Oncology 2000;59:24–27
              10.1159/000012132
              10895062
              cb7bf40b-0572-4847-8349-8b19024de739
              © 2000 S. Karger AG, Basel

              Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

              History
              Page count
              Figures: 1, Tables: 2, References: 20, Pages: 4
              Categories
              Clinical Study

              Oncology & Radiotherapy,Pathology,Surgery,Obstetrics & Gynecology,Pharmacology & Pharmaceutical medicine,Hematology
              Bladder cancer,Chemotherapy,Gemcitabine,Renal impairment,Patient management

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