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PO-0662 PHASE II STUDY OF PREOPERATIVE HELICAL TOMOTHERAPY WITH A SIMULTANEOUS INTEGRATED BOOST FOR RECTAL CANCER
S258
analyzed according to the criteria of the Japanese Research Society for Gastric Cancer by one radiologist. Results: Median follow-up was 56.3 months (range, 5.3-85.0 months). The 5-year regional failure free-survival (RFFS) rate was 63.6%. Regional failure (RF) as any component of first recurrence was 23.8% (91 patients), with isolated regional failure occurring in 49 patients (12.8%). Among 91 patients with RF, commonly involved recurrent lymph nodes were those in the No. 16b nodes (61.5%), No. 16a nodes (58.2%), No. 12 nodes (28.6%), No. 14 nodes (19.8%), No. 13 nodes (15.4%), and No. 9 nodes (15.4%). RFFS was adversely affected by advanced nodal stage (N3b vs. N3a) (hazard ratio, 2.02; 95% confidence interval, 1.40-2.91). The 5-year progression free-survival rate was 32.1% and overall survival 41.5%. Conclusions: The most prevalent nodal recurrence in patients with advanced gastric cancer was in the nodal basin outside D2 dissection field. Our findings may help physicians to construct lymph node target volume of gastric cancer after D2 dissection for radiation treatment. PO-0661 DOES SPLENECTOMY AFFECT THE OUTCOME OF POSTOPERATIVE RADIOCHEMOTHERAPY FOR GASTRIC CANCER? R. Suwinski1, J. Wydmanski1 1 Centre of Oncology - Institute MSC Gliwice, Radiation Oncology, Gliwice, Poland Purpose/Objective: The impact of splenectomy in the management of locally advanced gastric cancer remains controversial. An influence of splenectomy on tolerance and effectiveness of adjuvant postoperative radiochemotherapy has not been extensively studied. This created the basis for the present study. Materials and Methods: Between January 2001 and January 2006 351 patients had postoperative radiochemotherapy after surgery for gastric cancer. In general, prescription of radiochemotherapy was based on MacDonalds protocol, with loco-regional radiotherapy (45 Gy in 1.8 Gy per fraction over 5 weeks) and 5-Fu based chemotherapy (2 courses during radiotherapy, and 4 thereafter). Patients were in a good (ZUBROD 0) or fair (ZUBROD 1) performance (66% and 32% respectively). The highest proportion (71%) had pT3 tumors, while 12% and 17% had pT2 and pT3 tumors respectively. Only 78 patients (22%) appeared node negative. There were 254 males (72%) and 97 females (28%). Median age of the patients was 61 years (range 18-80 years). Weight loss of 10% or more was recorded in 173 patients (49%), while smaller loss in the remaining 178 patients (51%). Among 351 patients 120 (34%) had splenectomy, while 231 (66%) had not. The clinical characteristics of these two groups did not differ significantly. Survival curves were plotted using Kaplan-Meier method and compared using Cox f-test. Results: A statistical trend towards inferior survival after splenectomy was observed in a whole group of 351 patients (p=0.18, RR=1.22). Such trend was particularly apparent in a subset of patients with ≥10% weight loss (p=0.07, RR=1.41) and in a subset of patients younger than 70 years (p=0.12, RR=1.26). In 138 patients with both risk features (≥10% weight loss, age<70 years) splenectomy appeared to have a significant negative impact on overall survival (p=0.02, RR=1.59). The detrimental effect of splenectomy on survival resulted both from inferior loco-regional control and higher rate of distant metastases. Interestingly, the hematological tolerance of concurrent radiochemotherapy was better among the patients who had splenectomy, with 20% of patients with grade 1-2 leucopenia, compared to 47% of patients with grade 1-2 leucopenia among those with spleen preservation. Likewise, the average lymphocyte count at the end of chemotherapy was higher among the patients who had splenectomy, compared to those who did not have it (0.75 G/l vs. 0.30 G/l). Conclusions: While these results have limitations typical for the retrospective studies, the data suggest that splenectomy combined with postoperative radiochemotherapy for gastric cancer may result in inferior survival, particularly among young patients with ≥10% weight loss. PO-0662 PHASE II STUDY OF PREOPERATIVE HELICAL TOMOTHERAPY WITH A SIMULTANEOUS INTEGRATED BOOST FOR RECTAL CANCER A. Sermeus1, B. Engels2, K. Tournel2, H. Everaert3, A. Hoorens4, N. Christian2, G. Storme2, D. Verellen2, M. De Ridder2 1 Universitair Ziekenhuis Brussel, Gastro-Enterology, Brussels, Belgium 2 Universitair Ziekenhuis Brussel, Radiotherapy, Brussels, Belgium 3 Universitair Ziekenhuis Brussel, Nuclear Medicine, Brussels, Belgium 4 Universitair Ziekenhuis Brussel, Pathology, Brussels, Belgium
ESTRO 31
Purpose/Objective: The addition of concomitant chemotherapy to preoperative radiotherapy is considered the standard of care for patients with cT3-4 rectal cancer. The combined treatment modality increases the complete response rate and local control (LC), but has no impact on survival or the incidence of distant metastases. In addition, it is associated with considerable toxicity. As an alternative strategy, we explored prospectively, preoperative helical tomotherapy with a simultaneous integrated boost (SIB). Materials and Methods: A total of 108 patients were treated with intensity-modulated and image-guided radiotherapy using the Tomotherapy Hi-Art II system. A dose of 46 Gy, in daily fractions of 2 Gy, was delivered to the mesorectum and draining lymph nodes, without concomitant chemotherapy. Patients with an anticipated circumferential resection margin (CRM) of less than 2 mm, based on magnetic resonance imaging, received a SIB to the tumor up to a total dose of 55.2 Gy. Acute and late side effects were scored using the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0. Results: A total of 102 patients presented with cT3-4 tumors; 57 patients entered the boost group and 51 the no-boost group. One patient in the no-boost group developed a radio-hypersensitivity reaction, resulting in a complete tumor remission, a Grade 3 acute and Grade 5 late enteritis. No other Grade ≥3 acute toxicities occurred. With a median follow-up of 32 months, Grade ≥3 late gastrointestinal and urinary toxicity were observed in 6% and 4% of the patients, respectively. The actuarial 2-year LC, progression-free survival and overall survival were 98%, 79%, and 93%. Conclusions: Preoperative helical tomotherapy displays a favorable acute toxicity profile in patients with cT3-4 rectal cancer. A SIB can be safely administered in patients with a narrow CRM and resulted in a promising LC. This strategy is currently being compared to standard chemoradiotherapy in multicentric phase III trial (number NCT01224392) PO-0663 DOWNSIZING AND DOWNSTAGING OF RECTAL CANCER AFTER SHORT COURSE RADIOTHERAPY FOLLOWED BY DELAYED SURGERY S. Faria1, N. Kopek1, T. Hijal1, S. Liberman2, P. Charlebois2, B. Stein2, S. Meterissian2, A. Meguerditchian2, E. Debroux3, D. Tataryn4 1 McGill University MGH, Radiation Oncology, Montréal, Canada 2 McGill University, Surgery, Montréal, Canada 3 St Luc Hospital, Surgery, Montréal, Canada 4 St Mary's Hospital, Surgery, Montréal, Canada Purpose/Objective: Two common approaches to neoadjuvant therapy in locally advanced, resectable rectal cancer are short-course (25Gy/5 fractions) alone followed by immediate surgery, and long-course (50.4Gy/28 fractions) combined with chemotherapy followed by delayed surgery. Phase III studies comparing these two schedules show similar outcome and toxicity, except for downsizing and down staging. Complete response was on the order of 1% versus 16% after short and long course respectively. We performed a prospective phase II study using the short course regimen followed by delayed surgery (to give time for the rectal cancer to respond) to assess downsizing and down staging Materials and Methods: 48 patients were treated between October 2008 and October 2011. All had adenocarcinoma of rectum (up to 14 cm from the anal verge). All patients were staged with at least MRI, CT scan and colonoscopy (often also with EUS and PET scan). All patients received a pelvic irradiation dose of 25 Gy in 5 fractions without chemotherapy, followed by surgery 6-8 weeks after. MRI preoperative stage and rectal cancer size were compared with pathological stage and size. Toxicity was assessed using the CTC v3 scoring system. Results: 46 patients were stage T3Nx before radiotherapy, one T2N1 and one T4N1 (Table). Treatment was well tolerated. When manifested, acute GI toxicity was pronounced during the 2nd week after radiation, mostly with diarrhea: 33 patients had grade 0-1, 12 grade 2, and 3 grade 3. Median interval between last radiotherapy and surgery was 52 days. Abdominoperineal resection was performed in 13 and low anterior resection in 35 patients. Median distance of tumor from anal verge was 8 cm. Median tumor size before surgery was: 4cm (1.9-7.3cm) and after surgery was: 2cm (0 – 6cm). Four patients had complete response, and 3 cases had only foci of disease after the surgery (7 complete clinical responses). 24/48 (50%) patients had downstaging. 46/48 (96%) patients had reduction of the primary cancer, and in more than half of these cases there was greater than 50% reduction. 7/48 (15%) patients had significant morbidity after
analyzed according to the criteria of the Japanese Research Society for Gastric Cancer by one radiologist. Results: Median follow-up was 56.3 months (range, 5.3-85.0 months). The 5-year regional failure free-survival (RFFS) rate was 63.6%. Regional failure (RF) as any component of first recurrence was 23.8% (91 patients), with isolated regional failure occurring in 49 patients (12.8%). Among 91 patients with RF, commonly involved recurrent lymph nodes were those in the No. 16b nodes (61.5%), No. 16a nodes (58.2%), No. 12 nodes (28.6%), No. 14 nodes (19.8%), No. 13 nodes (15.4%), and No. 9 nodes (15.4%). RFFS was adversely affected by advanced nodal stage (N3b vs. N3a) (hazard ratio, 2.02; 95% confidence interval, 1.40-2.91). The 5-year progression free-survival rate was 32.1% and overall survival 41.5%. Conclusions: The most prevalent nodal recurrence in patients with advanced gastric cancer was in the nodal basin outside D2 dissection field. Our findings may help physicians to construct lymph node target volume of gastric cancer after D2 dissection for radiation treatment. PO-0661 DOES SPLENECTOMY AFFECT THE OUTCOME OF POSTOPERATIVE RADIOCHEMOTHERAPY FOR GASTRIC CANCER? R. Suwinski1, J. Wydmanski1 1 Centre of Oncology - Institute MSC Gliwice, Radiation Oncology, Gliwice, Poland Purpose/Objective: The impact of splenectomy in the management of locally advanced gastric cancer remains controversial. An influence of splenectomy on tolerance and effectiveness of adjuvant postoperative radiochemotherapy has not been extensively studied. This created the basis for the present study. Materials and Methods: Between January 2001 and January 2006 351 patients had postoperative radiochemotherapy after surgery for gastric cancer. In general, prescription of radiochemotherapy was based on MacDonalds protocol, with loco-regional radiotherapy (45 Gy in 1.8 Gy per fraction over 5 weeks) and 5-Fu based chemotherapy (2 courses during radiotherapy, and 4 thereafter). Patients were in a good (ZUBROD 0) or fair (ZUBROD 1) performance (66% and 32% respectively). The highest proportion (71%) had pT3 tumors, while 12% and 17% had pT2 and pT3 tumors respectively. Only 78 patients (22%) appeared node negative. There were 254 males (72%) and 97 females (28%). Median age of the patients was 61 years (range 18-80 years). Weight loss of 10% or more was recorded in 173 patients (49%), while smaller loss in the remaining 178 patients (51%). Among 351 patients 120 (34%) had splenectomy, while 231 (66%) had not. The clinical characteristics of these two groups did not differ significantly. Survival curves were plotted using Kaplan-Meier method and compared using Cox f-test. Results: A statistical trend towards inferior survival after splenectomy was observed in a whole group of 351 patients (p=0.18, RR=1.22). Such trend was particularly apparent in a subset of patients with ≥10% weight loss (p=0.07, RR=1.41) and in a subset of patients younger than 70 years (p=0.12, RR=1.26). In 138 patients with both risk features (≥10% weight loss, age<70 years) splenectomy appeared to have a significant negative impact on overall survival (p=0.02, RR=1.59). The detrimental effect of splenectomy on survival resulted both from inferior loco-regional control and higher rate of distant metastases. Interestingly, the hematological tolerance of concurrent radiochemotherapy was better among the patients who had splenectomy, with 20% of patients with grade 1-2 leucopenia, compared to 47% of patients with grade 1-2 leucopenia among those with spleen preservation. Likewise, the average lymphocyte count at the end of chemotherapy was higher among the patients who had splenectomy, compared to those who did not have it (0.75 G/l vs. 0.30 G/l). Conclusions: While these results have limitations typical for the retrospective studies, the data suggest that splenectomy combined with postoperative radiochemotherapy for gastric cancer may result in inferior survival, particularly among young patients with ≥10% weight loss. PO-0662 PHASE II STUDY OF PREOPERATIVE HELICAL TOMOTHERAPY WITH A SIMULTANEOUS INTEGRATED BOOST FOR RECTAL CANCER A. Sermeus1, B. Engels2, K. Tournel2, H. Everaert3, A. Hoorens4, N. Christian2, G. Storme2, D. Verellen2, M. De Ridder2 1 Universitair Ziekenhuis Brussel, Gastro-Enterology, Brussels, Belgium 2 Universitair Ziekenhuis Brussel, Radiotherapy, Brussels, Belgium 3 Universitair Ziekenhuis Brussel, Nuclear Medicine, Brussels, Belgium 4 Universitair Ziekenhuis Brussel, Pathology, Brussels, Belgium
ESTRO 31
Purpose/Objective: The addition of concomitant chemotherapy to preoperative radiotherapy is considered the standard of care for patients with cT3-4 rectal cancer. The combined treatment modality increases the complete response rate and local control (LC), but has no impact on survival or the incidence of distant metastases. In addition, it is associated with considerable toxicity. As an alternative strategy, we explored prospectively, preoperative helical tomotherapy with a simultaneous integrated boost (SIB). Materials and Methods: A total of 108 patients were treated with intensity-modulated and image-guided radiotherapy using the Tomotherapy Hi-Art II system. A dose of 46 Gy, in daily fractions of 2 Gy, was delivered to the mesorectum and draining lymph nodes, without concomitant chemotherapy. Patients with an anticipated circumferential resection margin (CRM) of less than 2 mm, based on magnetic resonance imaging, received a SIB to the tumor up to a total dose of 55.2 Gy. Acute and late side effects were scored using the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0. Results: A total of 102 patients presented with cT3-4 tumors; 57 patients entered the boost group and 51 the no-boost group. One patient in the no-boost group developed a radio-hypersensitivity reaction, resulting in a complete tumor remission, a Grade 3 acute and Grade 5 late enteritis. No other Grade ≥3 acute toxicities occurred. With a median follow-up of 32 months, Grade ≥3 late gastrointestinal and urinary toxicity were observed in 6% and 4% of the patients, respectively. The actuarial 2-year LC, progression-free survival and overall survival were 98%, 79%, and 93%. Conclusions: Preoperative helical tomotherapy displays a favorable acute toxicity profile in patients with cT3-4 rectal cancer. A SIB can be safely administered in patients with a narrow CRM and resulted in a promising LC. This strategy is currently being compared to standard chemoradiotherapy in multicentric phase III trial (number NCT01224392) PO-0663 DOWNSIZING AND DOWNSTAGING OF RECTAL CANCER AFTER SHORT COURSE RADIOTHERAPY FOLLOWED BY DELAYED SURGERY S. Faria1, N. Kopek1, T. Hijal1, S. Liberman2, P. Charlebois2, B. Stein2, S. Meterissian2, A. Meguerditchian2, E. Debroux3, D. Tataryn4 1 McGill University MGH, Radiation Oncology, Montréal, Canada 2 McGill University, Surgery, Montréal, Canada 3 St Luc Hospital, Surgery, Montréal, Canada 4 St Mary's Hospital, Surgery, Montréal, Canada Purpose/Objective: Two common approaches to neoadjuvant therapy in locally advanced, resectable rectal cancer are short-course (25Gy/5 fractions) alone followed by immediate surgery, and long-course (50.4Gy/28 fractions) combined with chemotherapy followed by delayed surgery. Phase III studies comparing these two schedules show similar outcome and toxicity, except for downsizing and down staging. Complete response was on the order of 1% versus 16% after short and long course respectively. We performed a prospective phase II study using the short course regimen followed by delayed surgery (to give time for the rectal cancer to respond) to assess downsizing and down staging Materials and Methods: 48 patients were treated between October 2008 and October 2011. All had adenocarcinoma of rectum (up to 14 cm from the anal verge). All patients were staged with at least MRI, CT scan and colonoscopy (often also with EUS and PET scan). All patients received a pelvic irradiation dose of 25 Gy in 5 fractions without chemotherapy, followed by surgery 6-8 weeks after. MRI preoperative stage and rectal cancer size were compared with pathological stage and size. Toxicity was assessed using the CTC v3 scoring system. Results: 46 patients were stage T3Nx before radiotherapy, one T2N1 and one T4N1 (Table). Treatment was well tolerated. When manifested, acute GI toxicity was pronounced during the 2nd week after radiation, mostly with diarrhea: 33 patients had grade 0-1, 12 grade 2, and 3 grade 3. Median interval between last radiotherapy and surgery was 52 days. Abdominoperineal resection was performed in 13 and low anterior resection in 35 patients. Median distance of tumor from anal verge was 8 cm. Median tumor size before surgery was: 4cm (1.9-7.3cm) and after surgery was: 2cm (0 – 6cm). Four patients had complete response, and 3 cases had only foci of disease after the surgery (7 complete clinical responses). 24/48 (50%) patients had downstaging. 46/48 (96%) patients had reduction of the primary cancer, and in more than half of these cases there was greater than 50% reduction. 7/48 (15%) patients had significant morbidity after