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P47 Capecitabine, oxaliplatin and bevacizumab as first line treatment for elderly patients with metastatic colorectal cancer: a multicenter phase II trial from Hellenic Oncology Research Group
Proffered papers, Posters Result(s): The most frequent level was Grade I. No relationship was found between toxicities and age, irrespective of type and level. Toxicity level was found to be higher in the pts who used more than 3 other medications p = 0.01. Statistically significant association was found between comorbidities and toxicity levels p = 0.04. Statistical significant correlation was found between WL and toxicity level P = 0.01. There was improvement in Qol through the evaluation of ADL, PS, and IADL after treatment p = 0.03. PS and IADL were statistically correlated with survival P = 0.02. Conclusion(s): Older colon cancer pts in good general condition and with controlled co-morbidities may receive Ch. The reason why the majority of patients had low toxicities may be attributed to the fact that all of them were properly selected. P46 Analysis of a monocentric cohort of elderly patients operated and treated by chemotherapy for colorectal cancer G. Des Guetz1 *, K. Chouahnia1 , V. Fran¸cois2 , Ph. Wind3 , J. B´enichou3 , G. Sebbane2 , J.-F. Mor`ere1 . 1 Department of Oncology, Hˆopital Avicenne, Bobigny, France, 2 Department of Geriatrics, Hˆopital Avicenne, Bobigny, France, 3 Department of Surgery, Hˆopital Avicenne, Bobigny, France Purpose of the study: Colorectal cancer (CRC) is often diagnosed for elderly patients (median age 65 years (y)) and the frequency increases until 80 y. Surgery is always the backbone of treatment. Chemotherapy is usually combined with surgery to cure patients in adjuvant setting and to prolong survival in metastatic setting. But few prospective CRC studies included elderly patients. So, it seems necessary to assess the treatment strategy for patients with CRC. Methods: From the surgical department data base all files from elderly patients (>70 y) operated on for CRC were analysed. The files of operated patients were systematically discussed in medical staff (MS) with oncologist and surgeons but without geriatric physician (GP). Results: Between 2004 and 2007; 88 patients were operated on for CRC (47 male, 41 female). Median age was 79 y (70−94). Half of patients were operated on in emergency (40/87). Initial stage were: I. 4 patients, II. 30 patients, III. 15 patients and IV. 20 patients. Twenty patients had cognitive impairment but this was not associated with emergency (50% vs 45% without dementia) or median duration of hospitalization (16 vs. 22 days) nor still with the ASA score. There was not relation between age and the ASA score. In metastasis setting (20 cases), chemotherapy was not done in 8 cases, often for patients with dementia, 5 cases (p = 0.002) and for patients with post-operative complications or severe comorbidities, 3 cases. In adjuvant setting (stage III, 15 cases), five patients were treated with chemotherapy but only one with standard treatment FOLFOX, others patients (10) without treatment have dementia (3) or were not able to be treated because they had complications notably. Conclusions: It does not seem to have blockade for the treatment of CRC in metastatic setting. However, therapeutic standards are difficult to propose for many frail patients. The benefit of a GP in MS will be assessed in a prospective approach. P47 Capecitabine, oxaliplatin and bevacizumab as first line treatment for elderly patients with metastatic colorectal cancer: a multicenter phase II trial from Hellenic Oncology Research Group L. Vamvakas, A. Prinari, A. Karampeazis *, N. Androulakis, S. Giassas, N. Xenidis, A. Polyzos, A. Athanasiadis, V. Georgoulias, J. Souglakos. Hellenic Oncology Research Group (HORG), Athens, Greece Purpose of the study: Approximately half of the patients with colorectal cancer are older than 70 years old. The present study was design in order to evaluate the efficacy and safety of combination chemotherapy (capecitabine and oxaliplatin-CAPOX regimen) and bevacizumab as first line treatment of elderly patients with metastatic colorectal cancer (mCRC). Method(s): After comprehensive geriatric assessment, fit and vulnerable patients aged more than 70 years with previously untreated mCRC were assigned to receive CAPOX+Bevacizumab. Patients were treated with Be-
S35 vacizumab (5 mg/kg) in combination with CAPOX (d1 : L-OHP 85 mg/m2 and d1−7 Capecitabine 1500 mg/m2 ) every 2 weeks. Result(s): Thirty-six patients were enrolled in the study. The median age was 76 years (70−86 years old). All patients were evaluable for toxicity and 30 for response. In an intension to treat analysis, one (3%) complete and 12 (40%) partial responses were achieved for an overall objective response (ORR) rate 43% (95& CI: 34−66%). In addition, 7 patients (23%) experienced stable disease and another ten (33%) presented disease progression. After a median follow-up of 11 months, the median time to tumor progression was 9.9 months (95& CI: 7.4–12.8). The median overall survival was not achieved, while the probability of 1-year and 2-years survival was 82% and 59%, respectively. Grade 3−4 neutropenia was observed in one (3%) patients, grade 3/4 diarrhea in four (11%), grade 3 fatigue in two (6%), and neurotoxicity grade 2 in three (8%) and grade 3 in one (3%) patients respectively. One patient presented grade 4 hypersensitivity reaction (3%). There was one (3%) sudden death three days after the first cycle. Conclusion(s): The combination of CAPOX + bevacizumab appears to be highly effective, well tolerated when comprehensive geriatric assessment is used for the patients’ evaluation. The study is continued until the completion of the planned accrual of 46 patients. P48 Upfront xelox in elderly patients presenting with metastatic colon cancer F. Geurs1 *, L.C. Silva Corten2 , I. Kempeneers2 , S. Ponette3 , J. Ponette3 , K. Bult´e3 . 1 Medical Oncology and Geriatrics Department, Regionaal Ziekenhuis Sint Maria, Halle, Belgium, 2 Abdominal Surgery, Regionaal Ziekenhuis Sint Maria, Halle, Belgium, 3 Gastroenterology, Regionaal Ziekenhuis Sint Maria, Halle, Belgium Purpose of the study: The management of metastatic colon cancer has much improved in the last decade, mainly by recent advances in chemotherapy (CT). The approach in elderly patients presenting with liver metastasis, and the colon primary still in situ, is somewhat more unclear. The timing of surgery, stenting and CT differs according to the authors. Method(s): We reviewed the files of 20 patients over 70 years (from 1/7/2004−1/7/2009) who presented with liver or peritoneal metastases of colon cancer. All these patients had little bowel complaints and no signs of obstruction. Median age was 74 y (70−87 y). 15 had sigmoid cancer, 4 had a cecal primary and 1 tumor was in the descending colon. They were treated with a standard and age adjusted chemotherapy regimen: namely XELOX (oxaliplatin 100 mg/m2 , capecitabin 1 g/m2 day 2−15). Result(s): Six patients died less than six weeks after starting chemotherapy. Response rate were 32%, TTP was 5 months (1−14 months) median survival was 7 months (1−24 months). 12 patients had subsequent colon surgery, in all cases a laparoscopic approach. Colon surgery was performed after a median of 18 w of CT. Two patients died postoperatively: 1 due to a pulmonary embolism and 1 due to liver failure on progressive liver metastases. Eight patients had subsequent second line treatment with irinotecan and tomudex (ref Ann Oncol, vol 20, june 2009, vii 75, P 0185). Conclusion(s): 1. Initial CT of patients presenting with liver metastasis of a colon primary, is feasible and gives no obstructive complications if surgery is planned after 18 weeks of chemotherapy. There was only one colonic stent placement necessary in our patient population. 2. One third of deaths occurred shortly after starting chemotherapy, notably after the first or second course of xelox, mostly due to multifactorial causes. 3. Prior chemotherapy doesn’t lead to a higher rate of postoperative complications nor a prolonged hospital stay.
S35 vacizumab (5 mg/kg) in combination with CAPOX (d1 : L-OHP 85 mg/m2 and d1−7 Capecitabine 1500 mg/m2 ) every 2 weeks. Result(s): Thirty-six patients were enrolled in the study. The median age was 76 years (70−86 years old). All patients were evaluable for toxicity and 30 for response. In an intension to treat analysis, one (3%) complete and 12 (40%) partial responses were achieved for an overall objective response (ORR) rate 43% (95& CI: 34−66%). In addition, 7 patients (23%) experienced stable disease and another ten (33%) presented disease progression. After a median follow-up of 11 months, the median time to tumor progression was 9.9 months (95& CI: 7.4–12.8). The median overall survival was not achieved, while the probability of 1-year and 2-years survival was 82% and 59%, respectively. Grade 3−4 neutropenia was observed in one (3%) patients, grade 3/4 diarrhea in four (11%), grade 3 fatigue in two (6%), and neurotoxicity grade 2 in three (8%) and grade 3 in one (3%) patients respectively. One patient presented grade 4 hypersensitivity reaction (3%). There was one (3%) sudden death three days after the first cycle. Conclusion(s): The combination of CAPOX + bevacizumab appears to be highly effective, well tolerated when comprehensive geriatric assessment is used for the patients’ evaluation. The study is continued until the completion of the planned accrual of 46 patients. P48 Upfront xelox in elderly patients presenting with metastatic colon cancer F. Geurs1 *, L.C. Silva Corten2 , I. Kempeneers2 , S. Ponette3 , J. Ponette3 , K. Bult´e3 . 1 Medical Oncology and Geriatrics Department, Regionaal Ziekenhuis Sint Maria, Halle, Belgium, 2 Abdominal Surgery, Regionaal Ziekenhuis Sint Maria, Halle, Belgium, 3 Gastroenterology, Regionaal Ziekenhuis Sint Maria, Halle, Belgium Purpose of the study: The management of metastatic colon cancer has much improved in the last decade, mainly by recent advances in chemotherapy (CT). The approach in elderly patients presenting with liver metastasis, and the colon primary still in situ, is somewhat more unclear. The timing of surgery, stenting and CT differs according to the authors. Method(s): We reviewed the files of 20 patients over 70 years (from 1/7/2004−1/7/2009) who presented with liver or peritoneal metastases of colon cancer. All these patients had little bowel complaints and no signs of obstruction. Median age was 74 y (70−87 y). 15 had sigmoid cancer, 4 had a cecal primary and 1 tumor was in the descending colon. They were treated with a standard and age adjusted chemotherapy regimen: namely XELOX (oxaliplatin 100 mg/m2 , capecitabin 1 g/m2 day 2−15). Result(s): Six patients died less than six weeks after starting chemotherapy. Response rate were 32%, TTP was 5 months (1−14 months) median survival was 7 months (1−24 months). 12 patients had subsequent colon surgery, in all cases a laparoscopic approach. Colon surgery was performed after a median of 18 w of CT. Two patients died postoperatively: 1 due to a pulmonary embolism and 1 due to liver failure on progressive liver metastases. Eight patients had subsequent second line treatment with irinotecan and tomudex (ref Ann Oncol, vol 20, june 2009, vii 75, P 0185). Conclusion(s): 1. Initial CT of patients presenting with liver metastasis of a colon primary, is feasible and gives no obstructive complications if surgery is planned after 18 weeks of chemotherapy. There was only one colonic stent placement necessary in our patient population. 2. One third of deaths occurred shortly after starting chemotherapy, notably after the first or second course of xelox, mostly due to multifactorial causes. 3. Prior chemotherapy doesn’t lead to a higher rate of postoperative complications nor a prolonged hospital stay.