Clinical outcome and toxicity of 3D-conformal radiotherapy combined with chemotherapy based on the Intergroup SWOG 9008/INT0116 study protocol for gastric cancer.

PURPOSE: To retrospectively evaluate the efficacy and toxicity of adjuvant radio-chemotherapy in patients with gastric cancer and to relate them to the outcome of the landmark INT0116 study that is criticized because of the high toxicity and poor treatment compliance. METHODS: A total of 102 patients who underwent postoperative fluorouracil (5-FU)-based radio-chemotherapy in our institution between 2004 and 2010 for stage IB-IV (AJCC 6th Edn.) gastric cancer were selected. Radiotherapy to 45 Gy was defined individually and delivered with 3D conformal technique. Chemotherapy was carried out during the first 4 and the last 3 days of radiotherapy with continuous infusion of 5-FU (400mg/m²/day) and leucovorin. Patients received an additional 3 cycles of chemotherapy of 5-FU (425mg/m²/day), mostly 1 before and 2 after radio-chemotherapy. Acute hematological and gastrointestinal toxicities were evaluated according to the CTC v3.0 scale. RESULTS: Stage distribution was as follows: IB-5 (5%), II-32 (31%), III-49 (48%), and IV-14 (14%). There were 96% R0 resections; 15% of the patients had a D2 resection. Seventy-four patients (72.5%) received all 5 planned cycles and 98 (96%) completed radiotherapy. The 3- and 5-year overall survival (OS) rates were 57% and 48%, respectively. Multivariate analysis showed that variables significantly affecting OS were pT3-T4, pN2-3, R1 resection and female gender. Only 2% of the patients experienced grade 3 gastrointestinal toxicity; 7% had grade 3 or higher hematological toxicity. CONCLUSIONS: We demonstrated better treatment tolerance, compliance, OS of adjuvant radio-chemotherapy for gastric cancer in comparison with INT0116 study. Conformal radiation techniques might have contributed to this improvement.

Target volume for postoperative radiotherapy in non-small cell lung cancer: results from a prospective trial.

BACKGROUND AND PURPOSE: A previous prospective trial reported that three-dimensional conformal postoperative radiotherapy (PORT) for pN2 NSCLC patients using a limited clinical target volume (CTV) had a late morbidity rate and pulmonary function that did not differ from those observed in pN1 patients treated with surgery without PORT. The aim of this study was to assess locoregional control and localization of failure in patients treated with PORT. MATERIALS AND METHODS: The pattern of locoregional failure was evaluated retrospectively in 151 of 171 patients included in the PORT arm. The CTV included the involved lymph node stations and those with a risk of invasion >10%. Competing risk analysis was used to assess the incidence of locoregional failure and its location outside the CTV. RESULTS: Overall survival at 5years was 27.1% with a median follow-up of 67months for 40 living patients. The 5-year cumulative incidence of locoregional failure was 19.4% (95% CI: 18.2-20.5%) including a failure rate of 2% (95% CI: 0-17%) in locations outside or at the border of the CTV. CONCLUSIONS: The use of limited CTV was associated with acceptable risk of geographic miss. Overall locoregional control was similar to that reported by other studies using PORT for pN2 patients.

Neoadjuvant treatment for unresectable rectal cancer: an interim analysis of a multicentre randomized study.

PURPOSE: To present an interim analysis of the trial comparing two neoadjuvant therapies for unresectable rectal cancer. METHODS: Patients with fixed cT3 or cT4 or locally recurrent rectal cancer without distant metastases were randomized to either 5 × 5 Gy and 3 courses of FOLFOX4 (schedule I) or 50.4 Gy delivered in 28 fractions given simultaneously with 5-Fu, leucovorin and oxaliplatin (schedule II). Surgery in both groups was performed 12 weeks after the beginning of radiation and 6 weeks after neoadjuvant treatment. RESULTS: 49 patients were treated according to schedule I and 48 according to schedule II. Grade III+ acute toxicity was observed in 26% of patients in group I and in 25% in group II. There were two toxic deaths, both in group II. The microscopically radical resection (primary endpoint) rate was 73% in group I and 71% in group II. Overall and severe postoperative complications were recorded in 27% and 9% of patients vs. 16% and 7%, respectively. Pathological complete response was observed in 21% of the patients in group I and in 9% in group II. CONCLUSIONS: The interim analysis revealed no major differences in acute toxicity and local efficacy between the two evaluated strategies.