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354Preoperative chemotherapy and hyperfractionated radiotherapy in advanced primary rectal cancer
$92 354
355
PREOPERATIVE CHEMOTHERAPY AND HYPERFRACTIONATED RADIOTHERAPY IN ADVANCED PRIMARY RECTAL CANCER
FLUOROURACIL AND HIGH-DOSE LEUCOVORIN WITH RADIOTHERAPY AS ADJUVANT THERAPY FOR RECTAL CANCER.
D. P6rez, J. Martin, R. Hem:tndez, F. Abed, G. Hem=tndez, F. Comma, E. Moneva, J. Su,~rez, C. Fuentes, A. Armijo, A. Perera, A. Soriano, A. Villar. Department Oncology-Radiotherapy. Hospital La Candelaria. Tenerife. Spain.
Purpose: A prospective randomized clinical tdal was conducted in pallents with advanced pdmary rectal cancer to compare the results of simple surgical resection vs a multimedal~ treatment including preoperative hyperfractionated radiotherapy (HR'I-) and oral chemotherapy before surgical resection. Patients and methods: A total of 33 patients (19 men, 14 women; mean age 62.6 ym, S.D. = 8.6) were allocated in the trial dudng a year period (1994-95). Pafients in the control (C) group (n=14) were submitted to surgical treatment alone. Those in the multimodality (M) group (n=19) received preoperative HRT and oral chemotherapy with UFT starUng jointly at day one. UFT was given by oral route (600 mg in dMded doses). HRT was administered in two daily 115 cGy fractions separated by 6 hrs, by 3 or 4 fields, using a Philips SL 25 linear accelerator (total dose 5000 cGy). Acute toxic effects were evaluated weekly. Surgery was performed 4 weeks after completion of HRT. Tumors were staged according to Astler-Coller classification, Results: a sta~-"Ucallysignificant downstaging was observed in the M group (p< .05). In 4 cases of this same group, complete disappearance of the tumor was observed at surgery and pathologically confirmed. Conclusions: Multimodalitytreatment in advanced pdmary rectal cancer results in better control of pelvic disease, reduction of tumor size and stage, and reduced hospitalization. No technical difficulties for surgery nor major toxicity were observed.
J. Girah, X. Maldonado, D. Rubio*, J. Naval¶, J. Montagut and M. Armengol¶. Deparments of Radiotherapy, Ontology* and Surgery~. Hospital Universitari Vail d'Hebron. Barcelona. Spain. PURPOSE. This phase II study was designed to evaluate the efficacy and toxicity of fluorouracil and high-dose leucovorin (5FU/LV)with pelvic irradiation for patients with macroscopical resected rectal or recto-sigmoid cancer. PATIENTS AND METHODS. Following surgery for stages IIIll primary (52) or recurrent rectal cancer (4), 56 patie,.+s received 8 cycles of 5-FU/LV and pelvic irradiation. 5-FU doses were ~10 mgr/m-" for cycles 2-3 and 300 mgr/m 2 for cycles 1 and 4-8. LV doses remained fixed at 200 mgr/m-'. Pelvic radiation began Ihe third week, between the first and second cycles. The total dose was 50.4 Gy. RESULTS. No severe tx~mplications had been recorded. The incidence of grade 3 diarrhea was 19%. Three patients presented leukopenia grade 3. In 44 patients (78%) the planned treatment could be administered. The median follow-up was 40 months (range 22-66). Seven patients had a local relapse (13%) and 6 developed distant metastasis (10%). The 3-year disease-free survival was 72% and the overall survival was 76%. CONCLUSIONS. These preliminary results show that combined O'~st-operative 5-FU/LV and pelvic radiotherapy are well tolerated and present a reasonable local and survival rates.
356
357
RESULTS OF EXTERNAL BEAM RADIATION AND IR-192 HDR IMPLANTS IN PATIENTS WITH ANAL CANAL CARCINOMAS.
IORT IN COMBINED MODALITY THERAPY OF RECTAL CARCINOMA.
E.Geyer, KKapp, G, F. Stuecklschweiger, F.Gebhart, A. Hackl; Division of Radiology, Department of Radiotherapy, Graz, Austria PURPOSE: Evaluation of the efficacy and toxicity of primary radiotherapy +1- chemotherapy in patients with squamous cell cancer of the anal canal, stage T1 -T2. MATERIALS: Between 1987-1996, 29 patients were treated with external beam radiation to the pelvis and groins in a split course fashion (30-,.50 Gy) with one IR 192 HDR implant (6 Gy) scheduled after 30Gy +1- concomitant 5 FU + MMC chemotherapy. RESULTS: Actuarial 5 year survival w a s 76.2 %. Of 27 patients with sufficient follow-up 21 pts or 78% achieved a complete response. Of these 16 had reosived additional ct'~.Treatment failures occured in 6 patients of whom 5 had denied systemic therapy as part of their treatment. The overall sphincter presentation rate w a s 83%. Radiation induced ulcers, of which all healed ~ l y , occured in 4 patients. There was no severe toxicity requiring inten'uption of
CONCLUSION: Primary radiotherapy yielded excellent results in stage T1-T2 lesions. Tumors more than 5 cm should be
treated with combined radio-chemoti~. Treatment toxicity was transient and acceptable.
Vllentlnl V., DeSantil M. Morglnti A.G,.TrodellaL., Genovesin., RatioC. ", Solo L, ", DogliettoG.B. * and Cellini. N. Islitutodl RadlologL',(DMslooedi Radiotempta), (') Illitutodi ClinicaChirurgica, U n ~ ' Cattolicadel S.Cuore,Rome,Italy BACKGROUND. Despite extensive therapeutic strategies, the risk of local recurrence of rectal cancer remains high. IORT seems to be a premising modafity for intensification of adjuvant radiotherapy.
PURPOSE. Aim of this study was to determine feasibility and results of a combined modality treatment for rectal carcinoma including preoperative external beam radiotherapy (EBRT), IORT + chemotherapy (c'r). MATERIAL AND METHODS. Between April 1990 and December 1995, 44 pts with "high risk" (T3NO-2 pdmapes) extrapedtoneal rectal tumors and 24 pts with "locally advanced" (2 pls: T3N3; 11 pts: T4N0-3; local recurrence: 11 pts) tumors entered a protocol wich included preop EBRT (38 Gy), surgery + IORT (10 Gy) in the high risk group, and preop EBRT (45-48 Gy) and concomitant CT (5-FU + MMC), surgery + IORT (10-15 Gy), and postop adjuvant CT (5-FU + folinic acid) in the locally advanced group. RESULTS. In high dsk group, acute (EORTC-RTOG) grade 3 skin toxicity, due to preoperative treatment, involved 1 pt (2.2%); among locally advanced cases, grade 3 hematological toxicity was observed in 1 pt (4.1%). In no cases the treatment was discontinued. Pedoperative mortality was 0%. Four anastomotic leakages, 1 pelvic infection and 5 wound infections were observed. No late toxicity occurred. After mean follow-up pedods of 25.9 and 28,3 months, 41 and 16 pts in the high risk and locally advanced groups respectively, are alive and disease-free. In 1 high dsk pt an anastomotic recurrence occurred, hi 4 pts with locally advanced tumors (1 T4 pdmary, 3 local recurrences) an unresectable tumor relapse developed locally. Distant metastases occurred in 3 high dsk cases and in 3 cases with a locally advanced tumor. Three-year actuarial survival was 100% both in high dsk and locally advanced primaries, while 68.2% in local recurrences CONCLUSION. The results of this study suggest that multimodal treatment (including IORT) in rectal cancer is safe, has no significant increase of mortality and morbidity, and show also a trend for local improvement.
355
PREOPERATIVE CHEMOTHERAPY AND HYPERFRACTIONATED RADIOTHERAPY IN ADVANCED PRIMARY RECTAL CANCER
FLUOROURACIL AND HIGH-DOSE LEUCOVORIN WITH RADIOTHERAPY AS ADJUVANT THERAPY FOR RECTAL CANCER.
D. P6rez, J. Martin, R. Hem:tndez, F. Abed, G. Hem=tndez, F. Comma, E. Moneva, J. Su,~rez, C. Fuentes, A. Armijo, A. Perera, A. Soriano, A. Villar. Department Oncology-Radiotherapy. Hospital La Candelaria. Tenerife. Spain.
Purpose: A prospective randomized clinical tdal was conducted in pallents with advanced pdmary rectal cancer to compare the results of simple surgical resection vs a multimedal~ treatment including preoperative hyperfractionated radiotherapy (HR'I-) and oral chemotherapy before surgical resection. Patients and methods: A total of 33 patients (19 men, 14 women; mean age 62.6 ym, S.D. = 8.6) were allocated in the trial dudng a year period (1994-95). Pafients in the control (C) group (n=14) were submitted to surgical treatment alone. Those in the multimodality (M) group (n=19) received preoperative HRT and oral chemotherapy with UFT starUng jointly at day one. UFT was given by oral route (600 mg in dMded doses). HRT was administered in two daily 115 cGy fractions separated by 6 hrs, by 3 or 4 fields, using a Philips SL 25 linear accelerator (total dose 5000 cGy). Acute toxic effects were evaluated weekly. Surgery was performed 4 weeks after completion of HRT. Tumors were staged according to Astler-Coller classification, Results: a sta~-"Ucallysignificant downstaging was observed in the M group (p< .05). In 4 cases of this same group, complete disappearance of the tumor was observed at surgery and pathologically confirmed. Conclusions: Multimodalitytreatment in advanced pdmary rectal cancer results in better control of pelvic disease, reduction of tumor size and stage, and reduced hospitalization. No technical difficulties for surgery nor major toxicity were observed.
J. Girah, X. Maldonado, D. Rubio*, J. Naval¶, J. Montagut and M. Armengol¶. Deparments of Radiotherapy, Ontology* and Surgery~. Hospital Universitari Vail d'Hebron. Barcelona. Spain. PURPOSE. This phase II study was designed to evaluate the efficacy and toxicity of fluorouracil and high-dose leucovorin (5FU/LV)with pelvic irradiation for patients with macroscopical resected rectal or recto-sigmoid cancer. PATIENTS AND METHODS. Following surgery for stages IIIll primary (52) or recurrent rectal cancer (4), 56 patie,.+s received 8 cycles of 5-FU/LV and pelvic irradiation. 5-FU doses were ~10 mgr/m-" for cycles 2-3 and 300 mgr/m 2 for cycles 1 and 4-8. LV doses remained fixed at 200 mgr/m-'. Pelvic radiation began Ihe third week, between the first and second cycles. The total dose was 50.4 Gy. RESULTS. No severe tx~mplications had been recorded. The incidence of grade 3 diarrhea was 19%. Three patients presented leukopenia grade 3. In 44 patients (78%) the planned treatment could be administered. The median follow-up was 40 months (range 22-66). Seven patients had a local relapse (13%) and 6 developed distant metastasis (10%). The 3-year disease-free survival was 72% and the overall survival was 76%. CONCLUSIONS. These preliminary results show that combined O'~st-operative 5-FU/LV and pelvic radiotherapy are well tolerated and present a reasonable local and survival rates.
356
357
RESULTS OF EXTERNAL BEAM RADIATION AND IR-192 HDR IMPLANTS IN PATIENTS WITH ANAL CANAL CARCINOMAS.
IORT IN COMBINED MODALITY THERAPY OF RECTAL CARCINOMA.
E.Geyer, KKapp, G, F. Stuecklschweiger, F.Gebhart, A. Hackl; Division of Radiology, Department of Radiotherapy, Graz, Austria PURPOSE: Evaluation of the efficacy and toxicity of primary radiotherapy +1- chemotherapy in patients with squamous cell cancer of the anal canal, stage T1 -T2. MATERIALS: Between 1987-1996, 29 patients were treated with external beam radiation to the pelvis and groins in a split course fashion (30-,.50 Gy) with one IR 192 HDR implant (6 Gy) scheduled after 30Gy +1- concomitant 5 FU + MMC chemotherapy. RESULTS: Actuarial 5 year survival w a s 76.2 %. Of 27 patients with sufficient follow-up 21 pts or 78% achieved a complete response. Of these 16 had reosived additional ct'~.Treatment failures occured in 6 patients of whom 5 had denied systemic therapy as part of their treatment. The overall sphincter presentation rate w a s 83%. Radiation induced ulcers, of which all healed ~ l y , occured in 4 patients. There was no severe toxicity requiring inten'uption of
CONCLUSION: Primary radiotherapy yielded excellent results in stage T1-T2 lesions. Tumors more than 5 cm should be
treated with combined radio-chemoti~. Treatment toxicity was transient and acceptable.
Vllentlnl V., DeSantil M. Morglnti A.G,.TrodellaL., Genovesin., RatioC. ", Solo L, ", DogliettoG.B. * and Cellini. N. Islitutodl RadlologL',(DMslooedi Radiotempta), (') Illitutodi ClinicaChirurgica, U n ~ ' Cattolicadel S.Cuore,Rome,Italy BACKGROUND. Despite extensive therapeutic strategies, the risk of local recurrence of rectal cancer remains high. IORT seems to be a premising modafity for intensification of adjuvant radiotherapy.
PURPOSE. Aim of this study was to determine feasibility and results of a combined modality treatment for rectal carcinoma including preoperative external beam radiotherapy (EBRT), IORT + chemotherapy (c'r). MATERIAL AND METHODS. Between April 1990 and December 1995, 44 pts with "high risk" (T3NO-2 pdmapes) extrapedtoneal rectal tumors and 24 pts with "locally advanced" (2 pls: T3N3; 11 pts: T4N0-3; local recurrence: 11 pts) tumors entered a protocol wich included preop EBRT (38 Gy), surgery + IORT (10 Gy) in the high risk group, and preop EBRT (45-48 Gy) and concomitant CT (5-FU + MMC), surgery + IORT (10-15 Gy), and postop adjuvant CT (5-FU + folinic acid) in the locally advanced group. RESULTS. In high dsk group, acute (EORTC-RTOG) grade 3 skin toxicity, due to preoperative treatment, involved 1 pt (2.2%); among locally advanced cases, grade 3 hematological toxicity was observed in 1 pt (4.1%). In no cases the treatment was discontinued. Pedoperative mortality was 0%. Four anastomotic leakages, 1 pelvic infection and 5 wound infections were observed. No late toxicity occurred. After mean follow-up pedods of 25.9 and 28,3 months, 41 and 16 pts in the high risk and locally advanced groups respectively, are alive and disease-free. In 1 high dsk pt an anastomotic recurrence occurred, hi 4 pts with locally advanced tumors (1 T4 pdmary, 3 local recurrences) an unresectable tumor relapse developed locally. Distant metastases occurred in 3 high dsk cases and in 3 cases with a locally advanced tumor. Three-year actuarial survival was 100% both in high dsk and locally advanced primaries, while 68.2% in local recurrences CONCLUSION. The results of this study suggest that multimodal treatment (including IORT) in rectal cancer is safe, has no significant increase of mortality and morbidity, and show also a trend for local improvement.