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EP-1247: Exclusive chemoradiation with Carboplatin-Taxol vs Folfox-4 in locally advanced esophageal cancer
S671 ESTRO 36 _______________________________________________________________________________________________
did not complete dCRT because of comorbidity or toxicity. Median follow up was 56 months. Median OS was 21 months and not significantly different between patients with SCC (20 [95% CI 15-25] months; n=73), AC-I (24 [95% CI 21-27] months; n=34) or AC-D+M (15 [95% CI 7-23] months; n=10). Median DFS was 19 months and, for SCC, AC-I and AC-D+M, DFS was 18 (95% CI 10-30), 21 (95% CI 21-27) and 15 (95% CI 7-23) months, respectively (p=0.29). Median time to isolated LRR was 64 months; for SCC, AC-I and AC-D+M, this was 64 (95% CI 0-129), 47 (95% CI 1-93) and 18 (95% CI 5-31) months, respectively (p=0.61). Multivariable analysis was adjusted for gender, age, completion of radiotherapy (all significantly associated with prognosis in univariable analysis), chemotherapy regimen and Charlson comorbidity score (both p=0.1 in univariable analysis). Age and failure to complete radiotherapy were significant predictors for overall survival. As compared to SCC, overall survival was similar for AC-I; HR 1.22 (95% CI 0.72-2.1) and AC-D+M; HR 1.93 (95% CI 0.9-4.0). Conclusion In our cohort no significant relationship was found between the histological subtype and long-term outcomes following dCRT for esophageal cancer, although, AC-D+M showed a trend towards poorer outcomes. Not only for SCC, but also for intestinal type adenocarcinomas of the esophagus, dCRT can be considered. EP-1247 Exclusive chemoradiation with CarboplatinTaxol vs Folfox-4 in locally advanced esophageal cancer. G. Crehange1, A. Bertaut2, J.F. Bosset3, J. Boustani3, M. Rouffiac1, F. Ghiringhelli4, C. Borg5, B. De Bari3, J. Buffet Miny3 1 Centre Georges-François Leclerc, Radiotherapy, Dijon, France 2 Centre Georges-François Leclerc, Biostatistics, Dijon, France 3 University Hospital Jean Minjoz, Radiation Oncology, Besançon, France 4 Centre Georges-François Leclerc, Medical oncology, Dijon, France 5 University Hospital Jean Minjoz, Medical Oncology, Besançon, France Purpose or Objective Exclusive chemoradiation delivering 50Gy of external beam radiotherapy (EBRT) combined with Cisplatinum and 5-FU remains the standard of care for locally advanced disease since a quarter century. The French PRODIGE 5 phase III trial has demonstrated the safety and the efficacy of FOLFOX-4 combined with exclusive 50Gy EBRT while the Dutch CROSS phase III trial showed an improvement in overall survival with Carboplatin and Taxol when combined with 41.4Gy in the preoperative setting. We sought to determine the feasibility and efficacy of exclusive EBRT with Carboplatin-Taxol compared to FOLFOX-4 regimen. Material and Methods Patients were matched 1:1 with respect to age at diagnosis (±5 years), stage (I-II vs III-IV), biopsy proven histology (squamous vs adeno) and topography (upper, middle or lower third or cardia). 46 patients followed the above criteria and remained for the final analysis : 23 patients were treated with FOLFOX-4 regimen (group A) and 23 patients with Carboplatin AUC2 mg/mL per min and Taxol 50mg/m2, weekly (group B). Comparison between the 2 groups was performed using Mac Nemar test for paired data. Statistical analyses were performed using SAS 9.3 software. All tests were two sided and P values were considered significant when less than 0.05. Results The mean age in group A was 69.4 years (12.5) and 72.4 years (12.6) in group B (p=ns). In each group, 11 patients
had a stage III disease at diagnosis (47.8%) with only 2 stage IV in group A (8.7%) vs none in group B. The median delivered RT doses were 50Gy [14-60] in group A while it was 50Gy [20-70] in group B. We found no difference in the compliance with chemotherapy in each group : 6 courses were delivered in 12 patients in group A (52.2%) and 14 patients in group B (60.9%) (p=0.51). No difference in dose reduction was observed between each group for each course of chemotherapy. After chemoradiation, G1 or higher esophagitis was observed in 5 patients (26.3%) in group A and 3 patients (13.0%) in group B of whom 0 vs 2 G3 were observed in group A and B, respectively. Four patients (21.1%) had a pulmonary infection in group A and 3 in group B (13.0%). Looking at haematological toxicity, 2 patients (8.7%) vs 4 patients (17.4%) had G3 neutropenia, with only 0 and 2 neutropenic fever in group A and B, respectively. No patient had G-CSF. Neither G3 anemia, nor G3 thrombopenia occured. After a median follow-up of 17.7 months [0.0-46.9], 25 patients had died, 14 in group A (60.9%) and 11 in group B (47.8%). The median PFS rates were 14 months in group A [7.7-NR] vs 12.1 months [4.4-NR] in group B (p=0.32). The median OS rates were 20.3 months in group A [6.239.3] vs 17.0 months [4.8-NR] in group B (p=0.82). Conclusion Exclusive chemoradiation with Carboplatin and Taxol seems feasible with similar toxicity and survival outcomes than FOLFOX-4. The safety and efficacy of the CROSS regimen needs to be tested prospectively with EBRT doses >41.4Gy in a phase II or III trial. EP-1248 Adjuvant radiotherapy for gastric cancer patients underwent gastrectomy and D2 lymph node dissection Y. Wang1, J.M. Hwang1, Y.K. Chang1, W.Y. Kao2, H.L. Wan2, S.Y. Chang2, C.C. Wu3 1 Taipei Tzu Chi Hospital, Radiation Oncology, New Taipei City, Taiwan 2 Taipei Tzu Chi Hospital, Medical Oncology, New Taipei City, Taiwan 3 Taipei Tzu Chi Hospital, General Surgery, New Taipei City, Taiwan Purpose or Objective The benefit of adjuvant chemoradiation (CRT) has been confirmed by the Intergroup 0116 (INT-0116) study. However, as D2 lymph node dissection has been linked to lower recurrence rate, the role of adjuvant radiotherapy (RT), whether with or without concurrent chemotherapy, following D2 dissection is controversial. The goal of this study is to review the clinical outcome of patients with locally advanced gastric adenocarcinoma underwent gastrectomy and D2 lymph node dissection with or without adjuvant RT. Material and Methods We reviewed 420 patients who were diagnosed with gastric cancer at Taipei TzuChi Hospital during Jan, 2008 to Sep, 2015, while excluding the following patients: those a) >80 years old, b) didn’t undergo gastrectomy and D2 dissection, c) with distant metastases at diagnosis, d) stage IA or IB without nodal metastases, or e) patients who had never been disease-free. The overall survival (OS) and disease-free survival (DFS) rates were compared between patients treated with or without adjuvant RT. Chi-square test or unpaired t-test were used to compare the age, gender, positive lymph nodes (LN) numbers, stage, and chemotherapy status distribution between these two groups. Results Of those selected patients, thirty-one underwent adjuvant RT and 40 didn’t. The characteristics were described in
did not complete dCRT because of comorbidity or toxicity. Median follow up was 56 months. Median OS was 21 months and not significantly different between patients with SCC (20 [95% CI 15-25] months; n=73), AC-I (24 [95% CI 21-27] months; n=34) or AC-D+M (15 [95% CI 7-23] months; n=10). Median DFS was 19 months and, for SCC, AC-I and AC-D+M, DFS was 18 (95% CI 10-30), 21 (95% CI 21-27) and 15 (95% CI 7-23) months, respectively (p=0.29). Median time to isolated LRR was 64 months; for SCC, AC-I and AC-D+M, this was 64 (95% CI 0-129), 47 (95% CI 1-93) and 18 (95% CI 5-31) months, respectively (p=0.61). Multivariable analysis was adjusted for gender, age, completion of radiotherapy (all significantly associated with prognosis in univariable analysis), chemotherapy regimen and Charlson comorbidity score (both p=0.1 in univariable analysis). Age and failure to complete radiotherapy were significant predictors for overall survival. As compared to SCC, overall survival was similar for AC-I; HR 1.22 (95% CI 0.72-2.1) and AC-D+M; HR 1.93 (95% CI 0.9-4.0). Conclusion In our cohort no significant relationship was found between the histological subtype and long-term outcomes following dCRT for esophageal cancer, although, AC-D+M showed a trend towards poorer outcomes. Not only for SCC, but also for intestinal type adenocarcinomas of the esophagus, dCRT can be considered. EP-1247 Exclusive chemoradiation with CarboplatinTaxol vs Folfox-4 in locally advanced esophageal cancer. G. Crehange1, A. Bertaut2, J.F. Bosset3, J. Boustani3, M. Rouffiac1, F. Ghiringhelli4, C. Borg5, B. De Bari3, J. Buffet Miny3 1 Centre Georges-François Leclerc, Radiotherapy, Dijon, France 2 Centre Georges-François Leclerc, Biostatistics, Dijon, France 3 University Hospital Jean Minjoz, Radiation Oncology, Besançon, France 4 Centre Georges-François Leclerc, Medical oncology, Dijon, France 5 University Hospital Jean Minjoz, Medical Oncology, Besançon, France Purpose or Objective Exclusive chemoradiation delivering 50Gy of external beam radiotherapy (EBRT) combined with Cisplatinum and 5-FU remains the standard of care for locally advanced disease since a quarter century. The French PRODIGE 5 phase III trial has demonstrated the safety and the efficacy of FOLFOX-4 combined with exclusive 50Gy EBRT while the Dutch CROSS phase III trial showed an improvement in overall survival with Carboplatin and Taxol when combined with 41.4Gy in the preoperative setting. We sought to determine the feasibility and efficacy of exclusive EBRT with Carboplatin-Taxol compared to FOLFOX-4 regimen. Material and Methods Patients were matched 1:1 with respect to age at diagnosis (±5 years), stage (I-II vs III-IV), biopsy proven histology (squamous vs adeno) and topography (upper, middle or lower third or cardia). 46 patients followed the above criteria and remained for the final analysis : 23 patients were treated with FOLFOX-4 regimen (group A) and 23 patients with Carboplatin AUC2 mg/mL per min and Taxol 50mg/m2, weekly (group B). Comparison between the 2 groups was performed using Mac Nemar test for paired data. Statistical analyses were performed using SAS 9.3 software. All tests were two sided and P values were considered significant when less than 0.05. Results The mean age in group A was 69.4 years (12.5) and 72.4 years (12.6) in group B (p=ns). In each group, 11 patients
had a stage III disease at diagnosis (47.8%) with only 2 stage IV in group A (8.7%) vs none in group B. The median delivered RT doses were 50Gy [14-60] in group A while it was 50Gy [20-70] in group B. We found no difference in the compliance with chemotherapy in each group : 6 courses were delivered in 12 patients in group A (52.2%) and 14 patients in group B (60.9%) (p=0.51). No difference in dose reduction was observed between each group for each course of chemotherapy. After chemoradiation, G1 or higher esophagitis was observed in 5 patients (26.3%) in group A and 3 patients (13.0%) in group B of whom 0 vs 2 G3 were observed in group A and B, respectively. Four patients (21.1%) had a pulmonary infection in group A and 3 in group B (13.0%). Looking at haematological toxicity, 2 patients (8.7%) vs 4 patients (17.4%) had G3 neutropenia, with only 0 and 2 neutropenic fever in group A and B, respectively. No patient had G-CSF. Neither G3 anemia, nor G3 thrombopenia occured. After a median follow-up of 17.7 months [0.0-46.9], 25 patients had died, 14 in group A (60.9%) and 11 in group B (47.8%). The median PFS rates were 14 months in group A [7.7-NR] vs 12.1 months [4.4-NR] in group B (p=0.32). The median OS rates were 20.3 months in group A [6.239.3] vs 17.0 months [4.8-NR] in group B (p=0.82). Conclusion Exclusive chemoradiation with Carboplatin and Taxol seems feasible with similar toxicity and survival outcomes than FOLFOX-4. The safety and efficacy of the CROSS regimen needs to be tested prospectively with EBRT doses >41.4Gy in a phase II or III trial. EP-1248 Adjuvant radiotherapy for gastric cancer patients underwent gastrectomy and D2 lymph node dissection Y. Wang1, J.M. Hwang1, Y.K. Chang1, W.Y. Kao2, H.L. Wan2, S.Y. Chang2, C.C. Wu3 1 Taipei Tzu Chi Hospital, Radiation Oncology, New Taipei City, Taiwan 2 Taipei Tzu Chi Hospital, Medical Oncology, New Taipei City, Taiwan 3 Taipei Tzu Chi Hospital, General Surgery, New Taipei City, Taiwan Purpose or Objective The benefit of adjuvant chemoradiation (CRT) has been confirmed by the Intergroup 0116 (INT-0116) study. However, as D2 lymph node dissection has been linked to lower recurrence rate, the role of adjuvant radiotherapy (RT), whether with or without concurrent chemotherapy, following D2 dissection is controversial. The goal of this study is to review the clinical outcome of patients with locally advanced gastric adenocarcinoma underwent gastrectomy and D2 lymph node dissection with or without adjuvant RT. Material and Methods We reviewed 420 patients who were diagnosed with gastric cancer at Taipei TzuChi Hospital during Jan, 2008 to Sep, 2015, while excluding the following patients: those a) >80 years old, b) didn’t undergo gastrectomy and D2 dissection, c) with distant metastases at diagnosis, d) stage IA or IB without nodal metastases, or e) patients who had never been disease-free. The overall survival (OS) and disease-free survival (DFS) rates were compared between patients treated with or without adjuvant RT. Chi-square test or unpaired t-test were used to compare the age, gender, positive lymph nodes (LN) numbers, stage, and chemotherapy status distribution between these two groups. Results Of those selected patients, thirty-one underwent adjuvant RT and 40 didn’t. The characteristics were described in