Capecitabine/RT Can Replace Cisplatin in Elderly Bladder Cancer Patients
The 30 reports in this special supplement to Oncology News International represent highlights of ongoing major clinical trials and new research presented at ASCO 2004 regarding state-of-the-art chemotherapeutic management of gastrointestinal and other cancers. Important developments in capecitabine as adjuvant therapy, novel targeted agents, and new combinations are discussed.
DETROIT-Capecitabine (Xeloda)can be safely delivered with radiationin elderly patients with urothelialcancers, and it provides effectivepalliation in localized and locally advancedurothelial cancers, accordingto Bhaumik Patel, MD (abstract 8165)."This offers a reasonable alternative inpatients who are elderly or have significantcomorbidities," said Dr. Patel, aHematology/Oncology Fellow atWayne State University, reporting ona study by Ulka Vaishampayan, MD,and colleagues.Concurrent cisplatin (Platinol) andexternal-beam radiation (RT) are commonlyused for patients with localizedor locally advanced urothelial cancerwho are not candidates for surgery,but elderly patients often cannot toleratefull-dose cisplatin. Capecitabine,is synergistic with RT in preclinicalstudies."The 5-year survival rates for radicalcystectomy or concurrent cisplatinand radiation for invasive transitional-cell urothelial cancer are 40% to50% and 50% to 60%, respectively.Cisplatin is poorly tolerated and frequentlycannot be used in the elderlypopulation due to a higher rate ofrenal, neurologic, cardiac, and gastrointestinaltoxicities," Dr. Patel said."Based on the compelling preclinicalsynergy, ease of administration, andgood tolerability data from our institution,we used concurrent capecitabineand radiation in patients withurothelial carcinoma who were notcandidates for cystectomy or cisplatin-based therapy."Retrospective ReviewDr. Patel reported data from a retrospectivereview of 14 patients whocould not have cisplatin owing to poorperformance status or comorbid conditions.The median age was 80 years(range, 46-88 years), and 13 patientswere older than 65 years. All had highgradetransitional-cell cancers. Patientswere treated with capecitabineon the days of radiation (Mondaythrough Friday) in daily doses of 1,200-1,800 mg/m2/day PO in two divideddoses. Concurrent RT (40-45 Gy) wasgiven using a four-field technique, todeliver the dose to a small pelvic fieldwith a boost to a total of 54-67 Gy, indaily fractions of 1.8-2.0 Gy.Seven of 14 patients required dosemodification because of toxicity, butonly three required treatment interruptions.Grade 3 toxicities were seenin 9 of 14 patients, including diarrheain 4, non-neutropenic infection in 1patient, and dehydration in 4 patients.No severe myelosuppression or handfootsyndrome was seen.One patient did not finish plannedradiation, and one has yet to finishtreatments. These two patients werenot evaluable for response. Two patientsdid not receive the boost, owingto grade 3 diarrhea in one patient andprogressive disease in the other.Strong ResponsesClinical complete response was seenin 10 of 12 (83%) evaluable patientswho finished prescribed RT. "Therewere 10 complete responses and 1 partialresponse-a very good partialresponse...with complete resolution ofthe pelvic mass and partial response inthe inguinal lymph node," Dr. Patelsaid.At a median follow-up duration of10.5 months in evaluable patients, onlyone patient has relapsed, with distalmetastases in the liver. No patientshave shown any superficial or invasivelocal recurrence. Four patients havedied: two from progressive disease,and two from exacerbation of pulmonaryfibrosis."The response rate is comparableto that seen in younger patients treatedwith cisplatin," Dr. Patel told ONI."Older patients can get through thecapecitabine regimen."The researchers concluded thatconcurrent capecitabine and RT is welltolerated, achieves effective palliationin localized and locally advancedurothelial cancer, offers an alternativeto cisplatin, and should be investigatedfurther in prospective trials.
