ABSTRACT
BACKGROUND: We studied the maximum tolerated dose (MTD) and efficacy of oxaliplatin added to capecitabine and radiotherapy (Capox-RT) as neoadjuvant therapy for rectal cancer. METHODS: T3-4 rectal cancer patients received escalating doses of oxaliplatin (day 1 and 29) with a fixed dose of capecitabine of 1000 mg/m(2) twice daily (days 1-14, 25-38) added to RT with 50.4 Gy and surgery after 6-8 weeks. The MTD, determined during phase I, was used in the subsequent phase II, in which R0 resection rate (a negative circumferential resection margin) was the primary end point. RESULTS: Twenty-one patients were evaluable. In the phase I part, oxaliplatin at 85 mg/m(2) was established as MTD. In phase II, the main toxicity was grade III diarrhea (18%). All patients underwent surgery, and 20 patients had a resectable tumor. An R0 was achieved in 17/21 patients, downstaging to T0-2 in 7/21 and a pCR in 2/21. CONCLUSION: Combination of Capox-RT has an acceptable acute toxicity profile and a high R0 resection rate of 81% in locally advanced rectal cancer. However the pCR rate was low.
Subject(s)
Adenocarcinoma/drug therapy , Adenocarcinoma/radiotherapy , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Neoadjuvant Therapy , Rectal Neoplasms/drug therapy , Rectal Neoplasms/radiotherapy , Adenocarcinoma/pathology , Adenocarcinoma/surgery , Adult , Aged , Antineoplastic Combined Chemotherapy Protocols/toxicity , Capecitabine , Deoxycytidine/administration & dosage , Deoxycytidine/analogs & derivatives , Deoxycytidine/toxicity , Dose-Response Relationship, Drug , Drug Administration Schedule , Female , Fluorouracil/administration & dosage , Fluorouracil/analogs & derivatives , Fluorouracil/toxicity , Humans , Male , Maximum Tolerated Dose , Middle Aged , Neoplasm Staging , Organoplatinum Compounds/administration & dosage , Organoplatinum Compounds/toxicity , Oxaliplatin , Pain Measurement , Particle Accelerators , Quality of Life , Radiotherapy Dosage , Rectal Neoplasms/pathology , Rectal Neoplasms/surgery , Rectum/pathology , Rectum/surgeryABSTRACT
BACKGROUND AND PURPOSE: In the Netherlands, the radiotherapy infrastructure is regulated by a Governmental license system. This requires timely and realistic prognostication of the needs for radiotherapy. In the present study, the latest prognoses (1993) and the realized changes in infrastructure are evaluated and a new prognosis for the period until 2010, which has been calculated using a new model, is presented. MATERIALS AND METHODS: Data on cancer incidence and use of radiotherapy were obtained from various published national reports and from a survey of all radiotherapy departments. RESULTS: The cancer incidence over the period 1993-1997 was about 10% higher than predicted. In 1996 and 1997, the percentage of new cancer patients treated with radiotherapy was 45.6 and 48.2%, respectively. The absolute number of newly irradiated patients was about 10% higher than foreseen in the prognosis. The needs for radiotherapy infrastructure not only depend on epidemiological data and changes in indications for radiotherapy, but also on changes in types of treatment with different workloads. A new model, which uses four categories for teletherapy and four categories for brachytherapy is described and a new prognosis for the required number of linear accelerators and staff up to the year 2010 is presented. CONCLUSION: The original prognosis on cancer incidence and radiotherapy patients underestimated the actual figures considerably. The new prognosis, based on a model, which not only accounts for an increase in number of patients, but also for changes in treatment techniques, is expected to more accurately predict and acquire the required radiotherapy capacity.
