- Email: [email protected]
35 oral Outcome and prognostic factors of primary breast sarcoma: a rare cancer network
Proffered papers
nodal status in the whole patient material. The analysis was therefore limited to 1152 node positive patients with 8 or more nodes removed. 552 patients had 1-3, and 600 patients 4+ positive nodes. Results: The overall 15 years survival in all 3083 patients was 4 1 % and 3 1 % (p<0.0001) after RT and no RT, respectively. A similar difference was found in the subgroup of pts with 8+ nodes removed (39 % vs 29 %, p=0.001). RT resulted in a substantial reduction in the 15 year Ioco-regional failure rate from 50 % to 9 % (p<0.0001) in 4+ positive node patients and from 28 % to 5 % (p<0.0001) in patients with 1-3 positive nodes, respectively). In contrast, the 15-year survival benefit after RT was most pronounced in patients with 1-3 positive nodes (59 % vs 48 %, p=0.02) compared to 2 1 % vs 12 %, (p=0.03), in patients with 4+ positive nodes. When further analyzed according to tumor size, the survival benefit was most pronounced in patients with smaller tumors, whereas the reduction in Ioco-regional failures was most pronounced in the patients with many positive nodes and large tumors. Conclusion: The survival benefit after postmastectomy RT to high-risk patients given adjuvant systemic therapy was most pronounced in patients with few positive nodes (1-3) and small tumors. In contrast do patients with large tumors and many positive nodes benefit the most in Ioco-regional control. The indication for RT seems therefore to be at least as good in patients with 1-3 positive nodes, and future consensus should be modified accordingly.
Supported by the Danish Cancer Society. 34 oral Implementation of breast IMRT via a randomised controlled trial: a report of the first year's experience
C.E. Coles ~, A.M. Moody 1, A.C.F. Hoole ~, N. Twyman ~, J.S. WilkinsOn,1 D. Routsis 1, C.B. Wilson,1 N.G. Burnet2 ~Addenbrooke's NHS Trust, Oncology Centre, Cambridge, United Kingdom 2University of Cambridge, Department of Oncology, Cambridge, United Kingdom Introduction: 2D radiotherapy (RT) breast plans can lead to substantial dose inhomogeneities, particularly in women with larger breasts. Planning studies have shown that breast dose homogeneity can be improved with 3D planning and IMRT. Despite advances in RT in other body sites, most breast cancer patients are planned with simple 2D RT techniques. We have implemented a randomised controlled trial (RCT), which is intended to prove the clinical benefit of forward-planned breast IMRT. It was adopted by the UK National Cancer Research Network (NCRN) in March 2003 and opened in April 2003. We report the dosimetry and timing study of the RT planning process from the first year of recruitment. Methods: Following 3D imaging, a standard plan, consisting of paired tangents, was produced for all patients. Plans were classified as having significant dose inhomogeneities if they exceeded the upper limit of ICRU 50 (>107% of prescribed dose). Those patients with satisfactory dose homogeneity were treated with standard RT (non-randomised group). Patients with significant dose inhomogeneities were randomised to standard breast RT (control) or IMRT (intervention). The intervention group were re-planned with forward-planned 'field in field' IMRT. A timing study recorded the RT process for 215 patients (trial and non-trial) planned for breast RT. Results: Approximately 1/3 had acceptable dose homogeneity (non-randomised group). 94/138 (68%) had significant dose inhomogeneities and were randomised to intervention or control. Mean difference in breast volume between randomised and non-randomised patients was 594cm 3 (p<0.0001, 95% CI
Monday, October 25, 2004 S15
41 lcm ~, 766cm3). In the intervention group, mean improvement in volumes >107% for IMRT plans was 64cm 3, (p<0.0001, 95% CI 4cm 3, 123cm3). There was no significant change in the volume <95% with IMRT. 3/45 (7%) could not be improved with IMRT without introducing a substantial volume <95% and these patients were treated using the standard plan. The median times for the total planning process were 20 minutes for the non-trial 2D plans, and 130 minutes for the 3D IMRT plans. However, the median times for breast Iocalisation and treatment were similar for trial and non-trial patients. Conclusion: Despite a significant difference in mean breast volume, there is an overlap between randomised and nonrandomised patients, showing that size alone does not discriminate for dose inhomogeneity. Therefore, we advocate screening for dose inhomogeneities rather than simply selecting larger women. Dosimetry analysis has confirmed that IMRT can significantly improve dose inhomogeneity. The timing study identified 3D planning as the most time consuming process which has assisted resource allocation, We recommend that new RT techniques for common cancers should be evaluated within a RCT to prove efficacy and facilitate change. 35 oral Outcome and prognostic factors sarcoma: a rare cancer network
of
primary
breast
G. Bousquet 1, C. Confavreux 2, C. Tunon de Lara 3, N. Magne4, P. Poortmans 5, E. Senkus ~, B. De Lafontan z, D. Azria 8, E. Lagneau 9, M. Ozsahin ~°, Y. Belkacemf ~Centre Oscar Lambret, Lille, France 2CRLC Leon Berard, Lyon, France 3CRLC F. Bergonie, Bordeaux, France 41nstitut Jules Bordet, Brussels, Belgium 5Dr. Bernard Verbeeten Instituut, Tilburg, The Netherlands 6Medical University, Gdansk, Poland 71nstitut Claudius Regaud, Toulouse, France 8CRLC Val d'Aurelle, Montpellier, France 9CHU, Besancon, France ~°CHUV, Lausanne, Switzerland Purpose: primary sarcoma of the breast (PSB) is a rare entity accounting for less than 1% of all breast malignancies. Treatment strategies are generally built mainly on the histologic features reported in small retrospective studies. Generally, surgical resection is the primary treatment for PBS. The role of radiation therapy (RT) and chemotherapy is not clear. Materials and methods: data from 99 patients with PSB treated between 1976 and 2003 were collected. Median age was 54 years (13-86). Median tumor size was 4.5 cm (1-11 cm). There were fibrosarcoma in 12 patients, angiosarcoma in 42, malignant fibrous histiocytoma in 14, liposarcoma in 7, osteogenic sarcoma in 2, and other types in 20. Tumor necrosis, cellular pleomorphism, and vascular invasion were observed respectively in 47%, 70%, and 32% of the specimen. Histologic grade included grade 1 tumors in 17 patients, grade 2 in 19, and grade 3 in 32. Axillary dissection was performed in 38 patients. Nodal involvement was detected only in 4 cases. Therapeutic strategy consisted of neoadjuvant chemotherapy followed by Iocoregional treatment in 19 patients, surgery alone in 38, and conservative surgery followed by RT in 30 patients. Surgery consisted of wide excision in 32, and mastectomy in 65 cases. Clear margins were obtained in 60 patients. Among the 20 patients who had close or positive margins, 15 (75%) had a secondary surgery. RT was implemented in 47 patients (50 Gy in 25 fr). Nine patients had supraclavicular, and 5 mammary nodal irradiation at a dose of 40-50 Gy. Four patients received 45-50 Gy to the axiUa. A boost of 6.5-16 Gy was delivered to the tumor bed in 18 patients. Chemotherapy was administered before or after surgery in 9 and 10 cases, respectively.
$16
Monday, October 25, 2004
Results: at the end of treatment, 8 patients had a residual tumor (microscopic in 5); 85 were in complete response (CR), and one patient developed bone metastases. After a median follow-up of 64 months, 38 patients presented a local relapse salvaged by surgery in 22 cases, and 37 patients developed lung and bone metastases. The 5- and 10-year disease-free survival (DFS) were 38% (+5) and 31% (+5), overall survival (OS) 52% (+6) and 51% (+6) and 5- and Ioco-regional relapse rate (LRR) were 46% (+6) and 54% (±7), respectively. Multivariate analysis revealed four favorable independent prognostic factors for local control: CR after treatment, no cellular pleomorphism/degeneration, histology other than angiosarcoma, and no menopause. For the DFS, the four favorable independent factors were absence of tumor necrosis, CR after treatment, no menopause, and histology other than angiosarcoma. Conclusions: angiosarcoma has a very bad prognosis despite aggressive therapy. This multicenter study demonstrated that the control of this rare disease after treatment is paramount of importance in order to increase local control and survival. The outcome can also depend on histologic issues such as tumor necrosis or cellular pleomorphism. 36 oral A National Survey of radiotherapy patient files in breast cancer
P. Van Houtte 1, N. Bourgois ~, F. Renard ~, P. Huget 3, P. Scalliet 2 ~lnstitut J. Bordet, Department of Radiotherapy, Brussels, Belgium 2Universit6 Catholique de Louvain, Department of Radiotherapy, Brussels, Belgium 3St. Augustinus Hospital, Department of Oncology, Antwerp, Belgium Rationale: In 1997, the Federal College of Radiotherapy issued recommendations regarding the clinical and pathological information required for a valid radiotherapy prescription. The College organised an external audit of radiotherapy files in 2003, using breast cancer as a model. The objective was to determine the level of compliance to the recommendations at the National level. Participation was voluntary. Methods and results: all the 26 Belgian radiotherapy departments accepted to be audited on an unselected series of 15 files (the last 15 breast cancer case treated in each department). The presence/absence of the following data were recorded: proper ID, familial history; side and quadrant involved; date and type of breast and lymph node surgery; clinical and pathological stage; details of pathology including type, grade, size, status of margins, hormonal receptors and Her2neu status; type of radiotherapy, boost, dose, fractionation and prescription signed by a certified radiation oncologist; chemotherapy (if any) and hormonal treatment (if any). 388 medical records were reviewed with data on 398 tumours. In all instances a hand-written prescription by the radiation oncologist was present. A conservative treatment was carried out in 283 cases and a sentinel biopsy in 98 with a wide variation from hospital to hospital. Pathological details were available in all but 2 files (in both case a patient addressed to a radiation oncologist by an other radiation oncologist), allowing for a valid prescription of radiotherapy. In the two incomplete files, pathological data had been communicated by phone only. Family history was recorded in 67%. Clinical stage was seldom reported (patients are seldom seen by the radiation oncologist before surgery). Tumour size was available in 390/395. Surgical margins were not specified in 7% (usually after mastectomy). Hormonal receptors were missing in 10% (usually because of short delay between surgery and start of RT).
Proffered papers
Conclusion: the College has been extremely satisfied with the high level of compliance of medical files with the College recommendations. In no instance was the radiotherapy prescribed without a hand-written, clear prescription and pathology had been verified appropriately in all (though 2/388 files contained only incomplete data). The RT prescription followed international recommendations in all cases.
Head and neck c a n c e r 37 oral Very accelerated compared to conventional radiotherapy in HNSCC : long-term results of a GORTEC phase III randomized trial
J. Bourhis 1, M. Lapeyre 2, J. Tortochaux3, M. Rives 4, P. Lesaunier 8, T. Benassi z, C. Lemanskl~, E. Bardet ~, P. Wibault 1, E. Benhamod l lnstitut Gustave Roussy, radiotherapy, villejuif, France 2CLCC, Radiotherapy, Nancy, France 3CLCC, Radiothearpy, Clermont Ferrand, France 4CLCC, Radiotherapy, Toulouse, France 5CLCC, Radiotherapy, Nantes, France Introduction: Considerable interest has been raised about altered fractionated radiotherapy (RT) for HNSCC, with the aim to increase the dose intensity of RT and subsequently the localregional control rate. In the present randomized study, a very accelerated regimen was compared to conventional RT in a series of patients with locally advanced HNSCC. This trial started in 1994 and long term results can now be presented. Material and methods: Between 1994 and 1998, 268 patients with a T3 or T4, N0-N3 (UICC 1997) HNSCC not amenable to surgery were randomized to receive either conventional RT delivering to the primary tumor 70 Gy / 7 weeks and 35 fractions of 2 Gy in 49 days or very accelerated RT delivering 62-64 Gy in 31-32 fractions of 2 Gy and 22-23 days (2 Gy / fraction BID). The most common tumor site was the oropharynx and most of the patients (70%) had T4 disease while a nodal involvement was present in most cases (72%). The distribution of the main patient and tumor characteristics was balanced between both arms. Results: With a median follow-up of more than 6 years, the benefit in local-regional control in favor of accelerated RT which was initially observed was confirmed, showing a 25 % and 24 % improvement at 2 and 5 years. A marginal benefit was also observed, both for disease free survival and overall survival in favor of the very intense regiment. Acute toxicity was severe and markedly increased with accelerated RT, as previously reported. Regarding late effects, no difference was seen between both arms, fore bone/mucosal necrosis, xerostomia, neck fibrosis, larynx and other toxicities. Conclusion: The very intense RT regimen provided a major benefit in local-regional control, however leading to a modest effect on survival and no significant increase in long term effect. 38 oral 7 fractions in 7 days versus 7 fractions in 5 days - an interim report on early treatment tolerance in CAIn-2 randomized clinical trial for head and neck cancer patients
K. Skladowski, M. Hutnik, A. Wygoda, M. Sygula, M. Golen, B. Pilecki, W. Przeorek, B. Maciejewski Centre of Oncology, I Radiotherapy, Gliwice, Poland Introduction: Over the last 10 years accelerated fractionation of 7 fractions in 7 days a week (CAIR) has been recognizing as a very effective primary radiation treatment for head and neck cancer patients and initiating to the standard practice at
nodal status in the whole patient material. The analysis was therefore limited to 1152 node positive patients with 8 or more nodes removed. 552 patients had 1-3, and 600 patients 4+ positive nodes. Results: The overall 15 years survival in all 3083 patients was 4 1 % and 3 1 % (p<0.0001) after RT and no RT, respectively. A similar difference was found in the subgroup of pts with 8+ nodes removed (39 % vs 29 %, p=0.001). RT resulted in a substantial reduction in the 15 year Ioco-regional failure rate from 50 % to 9 % (p<0.0001) in 4+ positive node patients and from 28 % to 5 % (p<0.0001) in patients with 1-3 positive nodes, respectively). In contrast, the 15-year survival benefit after RT was most pronounced in patients with 1-3 positive nodes (59 % vs 48 %, p=0.02) compared to 2 1 % vs 12 %, (p=0.03), in patients with 4+ positive nodes. When further analyzed according to tumor size, the survival benefit was most pronounced in patients with smaller tumors, whereas the reduction in Ioco-regional failures was most pronounced in the patients with many positive nodes and large tumors. Conclusion: The survival benefit after postmastectomy RT to high-risk patients given adjuvant systemic therapy was most pronounced in patients with few positive nodes (1-3) and small tumors. In contrast do patients with large tumors and many positive nodes benefit the most in Ioco-regional control. The indication for RT seems therefore to be at least as good in patients with 1-3 positive nodes, and future consensus should be modified accordingly.
Supported by the Danish Cancer Society. 34 oral Implementation of breast IMRT via a randomised controlled trial: a report of the first year's experience
C.E. Coles ~, A.M. Moody 1, A.C.F. Hoole ~, N. Twyman ~, J.S. WilkinsOn,1 D. Routsis 1, C.B. Wilson,1 N.G. Burnet2 ~Addenbrooke's NHS Trust, Oncology Centre, Cambridge, United Kingdom 2University of Cambridge, Department of Oncology, Cambridge, United Kingdom Introduction: 2D radiotherapy (RT) breast plans can lead to substantial dose inhomogeneities, particularly in women with larger breasts. Planning studies have shown that breast dose homogeneity can be improved with 3D planning and IMRT. Despite advances in RT in other body sites, most breast cancer patients are planned with simple 2D RT techniques. We have implemented a randomised controlled trial (RCT), which is intended to prove the clinical benefit of forward-planned breast IMRT. It was adopted by the UK National Cancer Research Network (NCRN) in March 2003 and opened in April 2003. We report the dosimetry and timing study of the RT planning process from the first year of recruitment. Methods: Following 3D imaging, a standard plan, consisting of paired tangents, was produced for all patients. Plans were classified as having significant dose inhomogeneities if they exceeded the upper limit of ICRU 50 (>107% of prescribed dose). Those patients with satisfactory dose homogeneity were treated with standard RT (non-randomised group). Patients with significant dose inhomogeneities were randomised to standard breast RT (control) or IMRT (intervention). The intervention group were re-planned with forward-planned 'field in field' IMRT. A timing study recorded the RT process for 215 patients (trial and non-trial) planned for breast RT. Results: Approximately 1/3 had acceptable dose homogeneity (non-randomised group). 94/138 (68%) had significant dose inhomogeneities and were randomised to intervention or control. Mean difference in breast volume between randomised and non-randomised patients was 594cm 3 (p<0.0001, 95% CI
Monday, October 25, 2004 S15
41 lcm ~, 766cm3). In the intervention group, mean improvement in volumes >107% for IMRT plans was 64cm 3, (p<0.0001, 95% CI 4cm 3, 123cm3). There was no significant change in the volume <95% with IMRT. 3/45 (7%) could not be improved with IMRT without introducing a substantial volume <95% and these patients were treated using the standard plan. The median times for the total planning process were 20 minutes for the non-trial 2D plans, and 130 minutes for the 3D IMRT plans. However, the median times for breast Iocalisation and treatment were similar for trial and non-trial patients. Conclusion: Despite a significant difference in mean breast volume, there is an overlap between randomised and nonrandomised patients, showing that size alone does not discriminate for dose inhomogeneity. Therefore, we advocate screening for dose inhomogeneities rather than simply selecting larger women. Dosimetry analysis has confirmed that IMRT can significantly improve dose inhomogeneity. The timing study identified 3D planning as the most time consuming process which has assisted resource allocation, We recommend that new RT techniques for common cancers should be evaluated within a RCT to prove efficacy and facilitate change. 35 oral Outcome and prognostic factors sarcoma: a rare cancer network
of
primary
breast
G. Bousquet 1, C. Confavreux 2, C. Tunon de Lara 3, N. Magne4, P. Poortmans 5, E. Senkus ~, B. De Lafontan z, D. Azria 8, E. Lagneau 9, M. Ozsahin ~°, Y. Belkacemf ~Centre Oscar Lambret, Lille, France 2CRLC Leon Berard, Lyon, France 3CRLC F. Bergonie, Bordeaux, France 41nstitut Jules Bordet, Brussels, Belgium 5Dr. Bernard Verbeeten Instituut, Tilburg, The Netherlands 6Medical University, Gdansk, Poland 71nstitut Claudius Regaud, Toulouse, France 8CRLC Val d'Aurelle, Montpellier, France 9CHU, Besancon, France ~°CHUV, Lausanne, Switzerland Purpose: primary sarcoma of the breast (PSB) is a rare entity accounting for less than 1% of all breast malignancies. Treatment strategies are generally built mainly on the histologic features reported in small retrospective studies. Generally, surgical resection is the primary treatment for PBS. The role of radiation therapy (RT) and chemotherapy is not clear. Materials and methods: data from 99 patients with PSB treated between 1976 and 2003 were collected. Median age was 54 years (13-86). Median tumor size was 4.5 cm (1-11 cm). There were fibrosarcoma in 12 patients, angiosarcoma in 42, malignant fibrous histiocytoma in 14, liposarcoma in 7, osteogenic sarcoma in 2, and other types in 20. Tumor necrosis, cellular pleomorphism, and vascular invasion were observed respectively in 47%, 70%, and 32% of the specimen. Histologic grade included grade 1 tumors in 17 patients, grade 2 in 19, and grade 3 in 32. Axillary dissection was performed in 38 patients. Nodal involvement was detected only in 4 cases. Therapeutic strategy consisted of neoadjuvant chemotherapy followed by Iocoregional treatment in 19 patients, surgery alone in 38, and conservative surgery followed by RT in 30 patients. Surgery consisted of wide excision in 32, and mastectomy in 65 cases. Clear margins were obtained in 60 patients. Among the 20 patients who had close or positive margins, 15 (75%) had a secondary surgery. RT was implemented in 47 patients (50 Gy in 25 fr). Nine patients had supraclavicular, and 5 mammary nodal irradiation at a dose of 40-50 Gy. Four patients received 45-50 Gy to the axiUa. A boost of 6.5-16 Gy was delivered to the tumor bed in 18 patients. Chemotherapy was administered before or after surgery in 9 and 10 cases, respectively.
$16
Monday, October 25, 2004
Results: at the end of treatment, 8 patients had a residual tumor (microscopic in 5); 85 were in complete response (CR), and one patient developed bone metastases. After a median follow-up of 64 months, 38 patients presented a local relapse salvaged by surgery in 22 cases, and 37 patients developed lung and bone metastases. The 5- and 10-year disease-free survival (DFS) were 38% (+5) and 31% (+5), overall survival (OS) 52% (+6) and 51% (+6) and 5- and Ioco-regional relapse rate (LRR) were 46% (+6) and 54% (±7), respectively. Multivariate analysis revealed four favorable independent prognostic factors for local control: CR after treatment, no cellular pleomorphism/degeneration, histology other than angiosarcoma, and no menopause. For the DFS, the four favorable independent factors were absence of tumor necrosis, CR after treatment, no menopause, and histology other than angiosarcoma. Conclusions: angiosarcoma has a very bad prognosis despite aggressive therapy. This multicenter study demonstrated that the control of this rare disease after treatment is paramount of importance in order to increase local control and survival. The outcome can also depend on histologic issues such as tumor necrosis or cellular pleomorphism. 36 oral A National Survey of radiotherapy patient files in breast cancer
P. Van Houtte 1, N. Bourgois ~, F. Renard ~, P. Huget 3, P. Scalliet 2 ~lnstitut J. Bordet, Department of Radiotherapy, Brussels, Belgium 2Universit6 Catholique de Louvain, Department of Radiotherapy, Brussels, Belgium 3St. Augustinus Hospital, Department of Oncology, Antwerp, Belgium Rationale: In 1997, the Federal College of Radiotherapy issued recommendations regarding the clinical and pathological information required for a valid radiotherapy prescription. The College organised an external audit of radiotherapy files in 2003, using breast cancer as a model. The objective was to determine the level of compliance to the recommendations at the National level. Participation was voluntary. Methods and results: all the 26 Belgian radiotherapy departments accepted to be audited on an unselected series of 15 files (the last 15 breast cancer case treated in each department). The presence/absence of the following data were recorded: proper ID, familial history; side and quadrant involved; date and type of breast and lymph node surgery; clinical and pathological stage; details of pathology including type, grade, size, status of margins, hormonal receptors and Her2neu status; type of radiotherapy, boost, dose, fractionation and prescription signed by a certified radiation oncologist; chemotherapy (if any) and hormonal treatment (if any). 388 medical records were reviewed with data on 398 tumours. In all instances a hand-written prescription by the radiation oncologist was present. A conservative treatment was carried out in 283 cases and a sentinel biopsy in 98 with a wide variation from hospital to hospital. Pathological details were available in all but 2 files (in both case a patient addressed to a radiation oncologist by an other radiation oncologist), allowing for a valid prescription of radiotherapy. In the two incomplete files, pathological data had been communicated by phone only. Family history was recorded in 67%. Clinical stage was seldom reported (patients are seldom seen by the radiation oncologist before surgery). Tumour size was available in 390/395. Surgical margins were not specified in 7% (usually after mastectomy). Hormonal receptors were missing in 10% (usually because of short delay between surgery and start of RT).
Proffered papers
Conclusion: the College has been extremely satisfied with the high level of compliance of medical files with the College recommendations. In no instance was the radiotherapy prescribed without a hand-written, clear prescription and pathology had been verified appropriately in all (though 2/388 files contained only incomplete data). The RT prescription followed international recommendations in all cases.
Head and neck c a n c e r 37 oral Very accelerated compared to conventional radiotherapy in HNSCC : long-term results of a GORTEC phase III randomized trial
J. Bourhis 1, M. Lapeyre 2, J. Tortochaux3, M. Rives 4, P. Lesaunier 8, T. Benassi z, C. Lemanskl~, E. Bardet ~, P. Wibault 1, E. Benhamod l lnstitut Gustave Roussy, radiotherapy, villejuif, France 2CLCC, Radiotherapy, Nancy, France 3CLCC, Radiothearpy, Clermont Ferrand, France 4CLCC, Radiotherapy, Toulouse, France 5CLCC, Radiotherapy, Nantes, France Introduction: Considerable interest has been raised about altered fractionated radiotherapy (RT) for HNSCC, with the aim to increase the dose intensity of RT and subsequently the localregional control rate. In the present randomized study, a very accelerated regimen was compared to conventional RT in a series of patients with locally advanced HNSCC. This trial started in 1994 and long term results can now be presented. Material and methods: Between 1994 and 1998, 268 patients with a T3 or T4, N0-N3 (UICC 1997) HNSCC not amenable to surgery were randomized to receive either conventional RT delivering to the primary tumor 70 Gy / 7 weeks and 35 fractions of 2 Gy in 49 days or very accelerated RT delivering 62-64 Gy in 31-32 fractions of 2 Gy and 22-23 days (2 Gy / fraction BID). The most common tumor site was the oropharynx and most of the patients (70%) had T4 disease while a nodal involvement was present in most cases (72%). The distribution of the main patient and tumor characteristics was balanced between both arms. Results: With a median follow-up of more than 6 years, the benefit in local-regional control in favor of accelerated RT which was initially observed was confirmed, showing a 25 % and 24 % improvement at 2 and 5 years. A marginal benefit was also observed, both for disease free survival and overall survival in favor of the very intense regiment. Acute toxicity was severe and markedly increased with accelerated RT, as previously reported. Regarding late effects, no difference was seen between both arms, fore bone/mucosal necrosis, xerostomia, neck fibrosis, larynx and other toxicities. Conclusion: The very intense RT regimen provided a major benefit in local-regional control, however leading to a modest effect on survival and no significant increase in long term effect. 38 oral 7 fractions in 7 days versus 7 fractions in 5 days - an interim report on early treatment tolerance in CAIn-2 randomized clinical trial for head and neck cancer patients
K. Skladowski, M. Hutnik, A. Wygoda, M. Sygula, M. Golen, B. Pilecki, W. Przeorek, B. Maciejewski Centre of Oncology, I Radiotherapy, Gliwice, Poland Introduction: Over the last 10 years accelerated fractionation of 7 fractions in 7 days a week (CAIR) has been recognizing as a very effective primary radiation treatment for head and neck cancer patients and initiating to the standard practice at