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

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/m² 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.

Gemcitabine and oxaliplatin combination: a multicenter phase II trial in unfit patients with locally advanced or metastatic urothelial cancer

“…Others studies combining gemcitabine and carboplatin demonstrated similar activity with manageable toxicity when they were used as first-line treatment of advanced bladder carcinoma in the elderly and those unfit for cisplatin-based chemotherapy. Therefore, it may be concluded that this combination of Gemox represents a reasonable choice for the treatment of such patients [11,12]. Despite the relatively poor clinical characteristics, the treatment was well tolerated.…”

Phase II trial of dose‐dense doxorubicin plus gemcitabine followed by paclitaxel plus carboplatin in patients with advanced urothelial carcinoma and impaired renal function

“…[2][3][4][5][6] Notably, these trials employed heterogeneous eligibility criteria and most did not distinguish patients ineligible for cisplatin based on renal function alone from patients ineligible for other reasons (eg, poor performance status). This distinction is important, as the former group of patients may benefit from more aggressive carboplatin-based regimens, whereas the latter patients may not tolerate such treatment.…”

“…The dose of doxorubicin was decreased by 20% for grade 4 mucositis. Dose modifications for paclitaxel plus carboplatin were as follows: if on the scheduled day of chemotherapy administration the absolute neutrophil count was <1000 cells/mm 3 or the platelet count was <100,000 cells/mm 3 , paclitaxel plus carboplatin was delayed for 1 week. If blood counts remained unsatisfactory after 2 1-week delays the patient was removed from the protocol.…”

Assessment and Management of Renal Impairment in Chemotherapy for Urogenital Cancer

“…Carles et al (37) reported the results of a Phase II study of GCarbo, which consisted of 1000 mg/m 2 of gemcitabine on Days 1 and 8, and carboplatin with the area under curve (AUC) of 5 on Day 1 and every 21 days. The cCR of 17 patients participating in this study was between 20 and 55 ml/min.…”