A phase II study of capecitabine and irinotecan in combination with concurrent pelvic radiotherapy (CapIri-RT) as neoadjuvant treatment of locally advanced rectal cancer
| Autor: | Armin Leitner, Rainer Grobholz, R.D. Hofheinz, Frank Willeke, Andreas Hochhaus, Karoline Horisberger, F. Wenz, A. Willer, Georg Kähler, Stefan Post, Uta Kraus-Tiefenbacher |
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| Rok vydání: | 2007 |
| Předmět: |
Adult
Male Cancer Research medicine.medical_specialty Colorectal cancer medicine.medical_treatment Phases of clinical research Adenocarcinoma Irinotecan Gastroenterology Deoxycytidine chemoradiotherapy Capecitabine locally advanced rectal cancer Internal medicine Antineoplastic Combined Chemotherapy Protocols Clinical Studies medicine Humans Neoadjuvant therapy Aged Aged 80 and over business.industry Rectal Neoplasms capecitabine Middle Aged medicine.disease Neoadjuvant Therapy Surgery Regimen Oncology Fluorouracil Camptothecin Female Neoplasm Recurrence Local business Chemoradiotherapy medicine.drug Follow-Up Studies |
| Zdroj: | British Journal of Cancer |
| ISSN: | 0007-0920 |
| Popis: | We sought to evaluate the efficacy and safety data of a combination regimen using weekly irinotecan in combination with capecitabine and concurrent radiotherapy (CapIri-RT) as neoadjuvant treatment in rectal cancer in a phase-II trial. Patients with rectal cancer clinical stages T3/4 Nx or N+ were recruited to receive irinotecan (50 mg m(-2) weekly) and capecitabine (500 mg m(-2) bid days 1-38) with a concurrent RT dose of 50.4 Gy. Surgery was scheduled 4-6 weeks after the completion of chemoradiation. A total of 36 patients (median age 62 years; m/f: 27:9) including three patients with local recurrence were enclosed onto the trial. The median distance of the tumour from the anal verge was 5 cm. The main toxicity observed was (NCI-CTC grades 1/2/3/4 (n)): Anaemia 23/9/-/-; leucocytopenia 12/7/7/2, diarrhoea 13/15/4/-, nausea/vomiting 9/10/2/-, and increased activity of transaminases 3/3/1/-. One patient had a reversible episode of ventricular fibrillation during chemoradiation, most probably caused by capecitabine. The relative dose intensity was (median/mean (%)): irinotecan 95/91, capecitabine 100/92). Thirty-four patients underwent surgery (anterior resection n=25; abdomino-perineal resection n=6; Hartmann's procedure n=3). R0-resection was accomplished in all patients. Two patients died in the postoperative course from septic complications. Pathological complete remission was observed in five out of 34 resected patients (15%), and nine patients showed microfoci of residual tumour (26%). After a median follow-up of 28 months one patient had developed a local recurrence, and five patients distant metastases. Three-year overall survival for all patients with surgery (excluding three patients treated for local relapse or with primary metastatic disease) was 80%. In summary, preoperative chemoradiation with CapIri-RT exhibits promising efficacy whereas showing managable toxicity. The local recurrence and distant failure rates observed after a median 28 months are low compared with standard 5-fluorouracil based therapy. |
| Databáze: | OpenAIRE |
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