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Chest Wall Radiation Alone for Breast Cancer Patients With 1–3 Positive Lymph Nodes Treated by Mastectomy
I. J. Radiation Oncology d Biology d Physics
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Volume 69, Number 3, Supplement, 2007
Results: The actuarial 5-yr rate of all complications was 27%. There was no statistically significant difference in the rate of major complications at 5 yrs in the PI group (0%) compared with 4.8% in the TTE group. No pts lost the reconstruction in the PI group and 3 pts lost the reconstruction in the TTE group. The 5-yr rate of minor complications was 33% for the PI group versus 18% for the TTE group (p = 0.48). In the PI group, 3 pts developed contracture and 1 pt developed fibrosis. In the TTE group, 3 pts developed contracture, 5 pts developed fibrosis and 3 pts developed infection. There were excellent/good cosmetic scores in 90% of the TTE group and 80% of the PI group (p = 0.22). On MVA, the type of reconstruction irradiated had no statistically significant impact on complication rates. No other factors including age, smoking, chemotherapy and endocrine therapy were predictive of an increased risk of complications. Conclusions: Pts treated with breast reconstruction and RT can experience a very low rate of major complications. We demonstrate no significant difference in the overall rate of major or minor complications between the TTE group and the PI groups. Therefore, post-mastectomy RT to either the temporary tissue expander or the permanent implant should be considered as acceptable treatment options in all eligible pts. Author Disclosure: P.R. Anderson, None; G. Freedman, None; T. Li, None; E. Ross, None; N. Topham, None; M. Morrow, None.
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Impact of Postoperative Radiation Therapy on Postmastectomy Breast Reconstruction
L. C. Keiler, H. Soltanian, R. Shenk, P. Silverman, R. Leeming, J. Lyons University Hospital of Cleveland, Cleveland, OH Purpose/Objective(s): To analyze the effects of postoperative radiation therapy on breast reconstruction following modified radical mastectomy for breast cancer. Materials/Methods: Between 1988 and 2006, 73 women were treated with post-mastectomy radiation therapy (RT) after breast reconstruction. Their RT records were retrospectively reviewed. Information regarding comorbid conditions, systemic therapy, reconstruction method, and RT technique was obtained and correlated with acute RT toxictiy, lymphedema, fat necrosis, telangiectasias, cosmetic outcome, and revision of reconstruction. Cosmesis was scored prospectively pre-RT and at follow-up using RTOG criteria. Results: The median duration of follow-up was 46 months (4 mo–11 yrs). The median age was 47 years (24–79 yrs). 62 patients received chemotherapy (15 neoadjuvant, 10 neoadjuvant + adjuvant, and 37 adjuvant). Reconstruction was immediate in 71 patients and delayed by .1 year for 2. All received RT following reconstruction with opposed tangents to a median dose of 50.4 Gy (6–56 Gy). 13 had a boost (8–16 Gy), 64 had supraclavicular fields (SCV) treated with a median dose of 46 Gy, and 19 had a posterior axillary boost (PAB) to with median mid-plane dose of 48 Gy. 40 patients had 1 cm (23) or 1/2 cm (17) of bolus applied to the chest wall every other day. Median time from reconstruction to RT was 7.6 months (2 mo–14 years). 37 had transverse rectus abdominus flap (TRAM), 25 had tissue expander (TE), 4 had latissimus dorsi flap (LD), and 7 had LD with a TE. 9 had revisions prior to RT (infection 3; skin necrosis 3; capsular contracture 3; poor cosmesis 1), and 13 had revisions following XRT (infection 2; skin necrosis 1; leaking implant 1; poor cosmesis 9). TRAM was less likely than TE to require a revision after XRT (9% vs. 35%; p = 0.016) and overall (16% vs. 48%; p = 0.006). Pre-RT cosmesis was excellent (27%), good (44%), fair (17%), or poor (13%). Post-RT cosmesis was excellent (22%), good (54%), fair (13%), or poor (11%). Pre and post-RT cosmesis did not differ significantly between reconstruction types. After RT, 16 developed fat necrosis, 7 developed telangiectasias, and 8 developed lymphedema. TRAMs were more likely to develop fat necrosis (38%; p = 0.0004). Fat necrosis, lymphedema, and telangiectasias did not reflect post-RT cosmetic score or predict for revision. Patients who received chemotherapy had worse cosmesis before RT, which persisted after RT (p = 0.037). There was a trend formore revisions in women receiving chemotherapy (34% vs. 9%; p = 0.1). No single agent or regimen was correlated with revision rate or cosmetic outcome. Hypertension, diabetes, alcohol use, smoking, bolus, RT dose, RT energy, RT boost, SCV, and PAB were not associated with cosmesis or revisions. Moist or dry desquamation and extent of RT skin erythema did not affect cosmesis or revisions. Time between reconstruction and RT did not predict for cosmetic outcome, RT toxicity, or revisions. Conclusions: Postmastectomy RT after breast reconstruction is well tolerated with 75% having good or excellent cosmetic outcomes. Neither acute RT toxicity nor fat necrosis predicted poorer cosmetic outcome or need for future revision. TE was more likely than TRAM reconstruction to require future surgical revision. Patients with TRAM reconstruction were more likely to experience fat necrosis, but this did not affect cosmesis. Author Disclosure: L.C. Keiler, None; H. Soltanian, None; R. Shenk, None; P. Silverman, None; R. Leeming, None; J. Lyons, None.
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Chest Wall Radiation Alone for Breast Cancer Patients With 1–3 Positive Lymph Nodes Treated by Mastectomy
R. F. Abi-Raad, S. M. MacDonald, M. A. Alm El-Din, S. I. Goldberg, A. G. Taghian Massachusetts General Hospital, Boston, MA Purpose/Objective(s): Although comprehensive postmastectomy radiation (PMRT) reduces locoregional recurrences (LRR) and improves overall survival in high-risk breast cancer patients, it is still controversial for patients with T1-T2 tumors and one to three positive lymph nodes (LN+ 1–3). The aim of this study was to evaluate whether chest wall (CW) radiation (RT) alone is enough to reduce LRR for this population in comparison with patients who did not receive PMRT or who received comprehensive PMRT. We also seek to determine possible predictors of LRR in this group. Materials/Methods: Between 1990 and 2004, 238 women with tumors \5 cm and LN+ 1–3 underwent mastectomy and axillary lymph node dissection at Massachusetts General Hospital. The median age was 54 (31–93). Tumor characteristics and treatment factors were compared between patients treated with (n = 73) and without (n = 165) radiotherapy. Forty-six received CW PMRT only, with (n = 11) or without (n = 35) internal mammary nodes, whereas 27 patients received CW and supraclavicular (S/C) PMRT, with (n = 15) or without (n = 12) axillary regions. Tangential fields were used to treat the CW (± boost) with a mean
Proceedings of the 49th Annual ASTRO Meeting radiotherapy dose of 5283 and 5592 cGy for patients receiving CW RT only and CW with peripheral nodes RT respectively. The S/C and axillary regions received a mean dose of 4921 and 4831 cGy respectively. Chemotherapy was administered to 35 patients, hormonal therapy to 54 and combined systemic treatment to 133. The median number of nodes excised was 14 (4–32). Results: The median follow-up was 80 months. In patients treated without PMRT, 13 developed LRR: 10 had recurrence in the CW, 5 in the axilla and 3 in the (S/C) fossa. 4 patients had multiple sites for recurrence. 6 patients developed an isolated LRR at the time of recurrence and 7 had synchronous distant metastasis. Kaplan-Meier method was used for survival analysis. By 10 years, the rate of LRR alone or with distant metastasis for patients treated with PMRT and without PMRT was lower (0% vs. 10.2% ± 3.1, p = 0.02), disease free survival superior (5.7 ± 2.8% vs 23.4 ± 4.2%, p = 0.02) respectively. However, the 10 years actuarial overall survival was 85.2 ± 7.2% for patients with PMRT and 77.7 ± 4% for patients without PMRT (p = 0.07). In the absence of PMRT, poor grade was the only factor associated with the risk of developing a LRR (p \ 0.001). Subset analyses of patients by RT treatment groups showed that additional irradiation to regional lymphatics had no effect on locoregional control. In particular, no patient in the PMRT group, regardless of tumor grade, experienced a LRR, neither in the CW PMRT only, nor in the CW with nodal PMRT. However, patients treated to the regional nodes had significantly more extracapsular extension (88% vs. 56%; p = 0.04) compared to the patients treated to the CW alone. Moreover, in nodal RT, 37% of the patients had over 20% positive nodes, compared to 17% in the CW RT only, noting that even though not significant, a trend toward the use of regional fields was considered more in this subpopulation (p = 0.06). Conclusions: Our data suggests that PMRT to the ipsilateral CW alone decreases LRR in selected patients with 1–3LN+ treated by MRM. However, comprehensive PMRT might be beneficial in patients with extranodal extension and other possible poor prognostic factors. Author Disclosure: R.F. Abi-Raad, None; S.M. MacDonald, None; M.A. Alm El-Din, None; S.I. Goldberg, None; A.G. Taghian, None.
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Definitive Results of the French FFCD-SFRO 2000-01 Study: Phase III Trial Comparing Chemoradiotherapy (Cisplatin and Infusional 5-FU) Followed by Gemcitabine vs. Gemcitabine Alone in Patients With Locally Advanced Non Metastatic Pancreatic Cancer
F. Mornex1, B. Chauffert2, F. Bonnetain3, J. Triboulet4, O. Bouche5, P. Rougier6, J. Bosset7, T. Aparicio8, F. Masskouri3, L. Bedenne9 1 Centre Hospitalier Lyon Sud, Lyon Pierre Benite, France, 2Centre Georges Francois Leclerc, Dijon, France, 3Federation Francophone de Cancerologie Digestive, Dijon, France, 4Hopital Claude Huriez, Lille, France, 5Hopital R Debre, Reims, France, 6Hopital Ambroise Pare, Boulogne, France, 7CHU Jean Minjoz, Besancon, France, 8Hopital Bichat, Paris, France, 9 CHRU Le Bocage, Dijon, France
Purpose/Objective(s): GITSG studies have shown a better survival after 5 FU-based chemoradiotherapy (CHRT) than radiotherapy or polychemotherapy alone in patients (pts) with locally advanced non metastatic pancreatic cancer. This randomized trial evaluated whether initial CHRT adds to modern Gemcitabine (G) in term of Overall Survival (OS). Materials/Methods: Pts with WHO status 0–2, proven pancreatic adenocarcinoma, without metastasis at CT-scan, and deemed non resectable, were randomized 1:1 between CHRT (60 Gy in 6 weeks, 2 Gy/fraction, concomitant with 5-FU, 300 mg/m2/24 h, continuous infusion, day 1–5 every week and cisplatin, 20 mg/m2/d, day 1–5 at week 1 and 5) or G (1000 mg/m2 weekly 7q8w) as induction treatment. Maintenance treatment was G (1000 mg/m2 weekly 3q4w) in both arms until progression or limiting toxicity. Stratification criteria were: center, WHO status and initial surgery. It was required to include 176 pts to detect an expected change in median OS from 6 to 12 months (bilateral a = 1% and b = 10%). Intent-to-treat (ITT) survival analysis used the Logrank and stratified Logrank tests. In addition, a per protocol analysis (n = 93) has been performed (major deviation pts have been excluded and pts with \75% RT dose or \75% G dose). Results: Between 03/00 and 02/07, 59 pts were randomized to CHRT and 60 to G. Median follow-up in 02/07 was 33 months. Pts characteristics were well balanced (CHRT/G) with mean age (60.1/62.4 years), sex ratio (1/1.4) and WHO status (0–1: 92%/77%, 2: 2%/23%). During the induction phase, more than 75% of the planned dose was completed in 83% pts for radiotherapy, 54% for 5-FU, 51% for cisplatin and 73.3% pts in the G arm. In CHRT and G arms, median survival was of 8.6/13 months, 1-year OS and PFS were respectively 32%/53% (stratified log-rank p = 0.05), and 14%/32% (stratified log-rank p = 0.09). Interestingly, per protocol 1-year survival rates were of 35%/64% (stratified log-rank p = 0.01), and Intent-to-treat ‘‘1-year WHO survival 0-1-2’’ of 24%/47% (stratified log-rank p = 0.004). CHRT or G related toxicities during induction were grade 3/4 leukopenia (18%/13%), thrombopenia (9%/0%), non-haematological toxicity (44%/18%). One treatment-related death was observed in the CHRT arm (aplasia). Maintenance G dose delivered was significantly higher in G arm (6464 versus 11681 mg/m2, p = 0.04). Conclusions: Definitive results show that Chemoradiation is not superior to Gemcitabine alone (OS: p = 0.05). Quality of life, reflected by WHO 0-1-2 survival rate is significantly better at 1 year after Gemcitabine alone. The scheme RT-5FU-Cisplatin is highly toxic when compared to Gemcitabine alone, precluding the maintenance Gemcitabine dose delivery, and should no longer be recommended. CHRT including new agents must be investigated. Author Disclosure: F. Mornex, None; B. Chauffert, None; F. Bonnetain, None; J. Triboulet, None; O. Bouche, None; P. Rougier, None; J. Bosset, None; T. Aparicio, None; F. Masskouri, None; L. Bedenne, None.
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A Phase II Study of Bevacizumab With Concurrent Capecitabine and Radiation Followed by Maintenance Gemcitabine and Bevacizumab for Locally Advanced Pancreatic Cancer: RTOG PA0411
C. H. Crane1, K. Winter2, W. Regine3, H. Safran4, T. Rich5, W. Curran6, R. Wolff1, C. Willett7 1 M.D. Anderson Cancer Center, Houston, TX, 2RTOG, Philadelphia, PA, 3University of Maryland, Baltimore, MD, 4Brown University, Providence, RI, 5University of Virginia, Charlottesville, VA, 6Thomas Jefferson University, Philadelphia, PA, 7Duke University, Durham, NC Purpose/Objective(s): The primary objective of this study was to assess the one-year overall survival of the combination of bevacizumab, capecitabine, and radiotherapy in patients with locally advanced, unresectable pancreatic cancer. Secondary endpoints included toxicity, objective response rate, and progression-free survival.
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Results: The actuarial 5-yr rate of all complications was 27%. There was no statistically significant difference in the rate of major complications at 5 yrs in the PI group (0%) compared with 4.8% in the TTE group. No pts lost the reconstruction in the PI group and 3 pts lost the reconstruction in the TTE group. The 5-yr rate of minor complications was 33% for the PI group versus 18% for the TTE group (p = 0.48). In the PI group, 3 pts developed contracture and 1 pt developed fibrosis. In the TTE group, 3 pts developed contracture, 5 pts developed fibrosis and 3 pts developed infection. There were excellent/good cosmetic scores in 90% of the TTE group and 80% of the PI group (p = 0.22). On MVA, the type of reconstruction irradiated had no statistically significant impact on complication rates. No other factors including age, smoking, chemotherapy and endocrine therapy were predictive of an increased risk of complications. Conclusions: Pts treated with breast reconstruction and RT can experience a very low rate of major complications. We demonstrate no significant difference in the overall rate of major or minor complications between the TTE group and the PI groups. Therefore, post-mastectomy RT to either the temporary tissue expander or the permanent implant should be considered as acceptable treatment options in all eligible pts. Author Disclosure: P.R. Anderson, None; G. Freedman, None; T. Li, None; E. Ross, None; N. Topham, None; M. Morrow, None.
133
Impact of Postoperative Radiation Therapy on Postmastectomy Breast Reconstruction
L. C. Keiler, H. Soltanian, R. Shenk, P. Silverman, R. Leeming, J. Lyons University Hospital of Cleveland, Cleveland, OH Purpose/Objective(s): To analyze the effects of postoperative radiation therapy on breast reconstruction following modified radical mastectomy for breast cancer. Materials/Methods: Between 1988 and 2006, 73 women were treated with post-mastectomy radiation therapy (RT) after breast reconstruction. Their RT records were retrospectively reviewed. Information regarding comorbid conditions, systemic therapy, reconstruction method, and RT technique was obtained and correlated with acute RT toxictiy, lymphedema, fat necrosis, telangiectasias, cosmetic outcome, and revision of reconstruction. Cosmesis was scored prospectively pre-RT and at follow-up using RTOG criteria. Results: The median duration of follow-up was 46 months (4 mo–11 yrs). The median age was 47 years (24–79 yrs). 62 patients received chemotherapy (15 neoadjuvant, 10 neoadjuvant + adjuvant, and 37 adjuvant). Reconstruction was immediate in 71 patients and delayed by .1 year for 2. All received RT following reconstruction with opposed tangents to a median dose of 50.4 Gy (6–56 Gy). 13 had a boost (8–16 Gy), 64 had supraclavicular fields (SCV) treated with a median dose of 46 Gy, and 19 had a posterior axillary boost (PAB) to with median mid-plane dose of 48 Gy. 40 patients had 1 cm (23) or 1/2 cm (17) of bolus applied to the chest wall every other day. Median time from reconstruction to RT was 7.6 months (2 mo–14 years). 37 had transverse rectus abdominus flap (TRAM), 25 had tissue expander (TE), 4 had latissimus dorsi flap (LD), and 7 had LD with a TE. 9 had revisions prior to RT (infection 3; skin necrosis 3; capsular contracture 3; poor cosmesis 1), and 13 had revisions following XRT (infection 2; skin necrosis 1; leaking implant 1; poor cosmesis 9). TRAM was less likely than TE to require a revision after XRT (9% vs. 35%; p = 0.016) and overall (16% vs. 48%; p = 0.006). Pre-RT cosmesis was excellent (27%), good (44%), fair (17%), or poor (13%). Post-RT cosmesis was excellent (22%), good (54%), fair (13%), or poor (11%). Pre and post-RT cosmesis did not differ significantly between reconstruction types. After RT, 16 developed fat necrosis, 7 developed telangiectasias, and 8 developed lymphedema. TRAMs were more likely to develop fat necrosis (38%; p = 0.0004). Fat necrosis, lymphedema, and telangiectasias did not reflect post-RT cosmetic score or predict for revision. Patients who received chemotherapy had worse cosmesis before RT, which persisted after RT (p = 0.037). There was a trend formore revisions in women receiving chemotherapy (34% vs. 9%; p = 0.1). No single agent or regimen was correlated with revision rate or cosmetic outcome. Hypertension, diabetes, alcohol use, smoking, bolus, RT dose, RT energy, RT boost, SCV, and PAB were not associated with cosmesis or revisions. Moist or dry desquamation and extent of RT skin erythema did not affect cosmesis or revisions. Time between reconstruction and RT did not predict for cosmetic outcome, RT toxicity, or revisions. Conclusions: Postmastectomy RT after breast reconstruction is well tolerated with 75% having good or excellent cosmetic outcomes. Neither acute RT toxicity nor fat necrosis predicted poorer cosmetic outcome or need for future revision. TE was more likely than TRAM reconstruction to require future surgical revision. Patients with TRAM reconstruction were more likely to experience fat necrosis, but this did not affect cosmesis. Author Disclosure: L.C. Keiler, None; H. Soltanian, None; R. Shenk, None; P. Silverman, None; R. Leeming, None; J. Lyons, None.
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Chest Wall Radiation Alone for Breast Cancer Patients With 1–3 Positive Lymph Nodes Treated by Mastectomy
R. F. Abi-Raad, S. M. MacDonald, M. A. Alm El-Din, S. I. Goldberg, A. G. Taghian Massachusetts General Hospital, Boston, MA Purpose/Objective(s): Although comprehensive postmastectomy radiation (PMRT) reduces locoregional recurrences (LRR) and improves overall survival in high-risk breast cancer patients, it is still controversial for patients with T1-T2 tumors and one to three positive lymph nodes (LN+ 1–3). The aim of this study was to evaluate whether chest wall (CW) radiation (RT) alone is enough to reduce LRR for this population in comparison with patients who did not receive PMRT or who received comprehensive PMRT. We also seek to determine possible predictors of LRR in this group. Materials/Methods: Between 1990 and 2004, 238 women with tumors \5 cm and LN+ 1–3 underwent mastectomy and axillary lymph node dissection at Massachusetts General Hospital. The median age was 54 (31–93). Tumor characteristics and treatment factors were compared between patients treated with (n = 73) and without (n = 165) radiotherapy. Forty-six received CW PMRT only, with (n = 11) or without (n = 35) internal mammary nodes, whereas 27 patients received CW and supraclavicular (S/C) PMRT, with (n = 15) or without (n = 12) axillary regions. Tangential fields were used to treat the CW (± boost) with a mean
Proceedings of the 49th Annual ASTRO Meeting radiotherapy dose of 5283 and 5592 cGy for patients receiving CW RT only and CW with peripheral nodes RT respectively. The S/C and axillary regions received a mean dose of 4921 and 4831 cGy respectively. Chemotherapy was administered to 35 patients, hormonal therapy to 54 and combined systemic treatment to 133. The median number of nodes excised was 14 (4–32). Results: The median follow-up was 80 months. In patients treated without PMRT, 13 developed LRR: 10 had recurrence in the CW, 5 in the axilla and 3 in the (S/C) fossa. 4 patients had multiple sites for recurrence. 6 patients developed an isolated LRR at the time of recurrence and 7 had synchronous distant metastasis. Kaplan-Meier method was used for survival analysis. By 10 years, the rate of LRR alone or with distant metastasis for patients treated with PMRT and without PMRT was lower (0% vs. 10.2% ± 3.1, p = 0.02), disease free survival superior (5.7 ± 2.8% vs 23.4 ± 4.2%, p = 0.02) respectively. However, the 10 years actuarial overall survival was 85.2 ± 7.2% for patients with PMRT and 77.7 ± 4% for patients without PMRT (p = 0.07). In the absence of PMRT, poor grade was the only factor associated with the risk of developing a LRR (p \ 0.001). Subset analyses of patients by RT treatment groups showed that additional irradiation to regional lymphatics had no effect on locoregional control. In particular, no patient in the PMRT group, regardless of tumor grade, experienced a LRR, neither in the CW PMRT only, nor in the CW with nodal PMRT. However, patients treated to the regional nodes had significantly more extracapsular extension (88% vs. 56%; p = 0.04) compared to the patients treated to the CW alone. Moreover, in nodal RT, 37% of the patients had over 20% positive nodes, compared to 17% in the CW RT only, noting that even though not significant, a trend toward the use of regional fields was considered more in this subpopulation (p = 0.06). Conclusions: Our data suggests that PMRT to the ipsilateral CW alone decreases LRR in selected patients with 1–3LN+ treated by MRM. However, comprehensive PMRT might be beneficial in patients with extranodal extension and other possible poor prognostic factors. Author Disclosure: R.F. Abi-Raad, None; S.M. MacDonald, None; M.A. Alm El-Din, None; S.I. Goldberg, None; A.G. Taghian, None.
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Definitive Results of the French FFCD-SFRO 2000-01 Study: Phase III Trial Comparing Chemoradiotherapy (Cisplatin and Infusional 5-FU) Followed by Gemcitabine vs. Gemcitabine Alone in Patients With Locally Advanced Non Metastatic Pancreatic Cancer
F. Mornex1, B. Chauffert2, F. Bonnetain3, J. Triboulet4, O. Bouche5, P. Rougier6, J. Bosset7, T. Aparicio8, F. Masskouri3, L. Bedenne9 1 Centre Hospitalier Lyon Sud, Lyon Pierre Benite, France, 2Centre Georges Francois Leclerc, Dijon, France, 3Federation Francophone de Cancerologie Digestive, Dijon, France, 4Hopital Claude Huriez, Lille, France, 5Hopital R Debre, Reims, France, 6Hopital Ambroise Pare, Boulogne, France, 7CHU Jean Minjoz, Besancon, France, 8Hopital Bichat, Paris, France, 9 CHRU Le Bocage, Dijon, France
Purpose/Objective(s): GITSG studies have shown a better survival after 5 FU-based chemoradiotherapy (CHRT) than radiotherapy or polychemotherapy alone in patients (pts) with locally advanced non metastatic pancreatic cancer. This randomized trial evaluated whether initial CHRT adds to modern Gemcitabine (G) in term of Overall Survival (OS). Materials/Methods: Pts with WHO status 0–2, proven pancreatic adenocarcinoma, without metastasis at CT-scan, and deemed non resectable, were randomized 1:1 between CHRT (60 Gy in 6 weeks, 2 Gy/fraction, concomitant with 5-FU, 300 mg/m2/24 h, continuous infusion, day 1–5 every week and cisplatin, 20 mg/m2/d, day 1–5 at week 1 and 5) or G (1000 mg/m2 weekly 7q8w) as induction treatment. Maintenance treatment was G (1000 mg/m2 weekly 3q4w) in both arms until progression or limiting toxicity. Stratification criteria were: center, WHO status and initial surgery. It was required to include 176 pts to detect an expected change in median OS from 6 to 12 months (bilateral a = 1% and b = 10%). Intent-to-treat (ITT) survival analysis used the Logrank and stratified Logrank tests. In addition, a per protocol analysis (n = 93) has been performed (major deviation pts have been excluded and pts with \75% RT dose or \75% G dose). Results: Between 03/00 and 02/07, 59 pts were randomized to CHRT and 60 to G. Median follow-up in 02/07 was 33 months. Pts characteristics were well balanced (CHRT/G) with mean age (60.1/62.4 years), sex ratio (1/1.4) and WHO status (0–1: 92%/77%, 2: 2%/23%). During the induction phase, more than 75% of the planned dose was completed in 83% pts for radiotherapy, 54% for 5-FU, 51% for cisplatin and 73.3% pts in the G arm. In CHRT and G arms, median survival was of 8.6/13 months, 1-year OS and PFS were respectively 32%/53% (stratified log-rank p = 0.05), and 14%/32% (stratified log-rank p = 0.09). Interestingly, per protocol 1-year survival rates were of 35%/64% (stratified log-rank p = 0.01), and Intent-to-treat ‘‘1-year WHO survival 0-1-2’’ of 24%/47% (stratified log-rank p = 0.004). CHRT or G related toxicities during induction were grade 3/4 leukopenia (18%/13%), thrombopenia (9%/0%), non-haematological toxicity (44%/18%). One treatment-related death was observed in the CHRT arm (aplasia). Maintenance G dose delivered was significantly higher in G arm (6464 versus 11681 mg/m2, p = 0.04). Conclusions: Definitive results show that Chemoradiation is not superior to Gemcitabine alone (OS: p = 0.05). Quality of life, reflected by WHO 0-1-2 survival rate is significantly better at 1 year after Gemcitabine alone. The scheme RT-5FU-Cisplatin is highly toxic when compared to Gemcitabine alone, precluding the maintenance Gemcitabine dose delivery, and should no longer be recommended. CHRT including new agents must be investigated. Author Disclosure: F. Mornex, None; B. Chauffert, None; F. Bonnetain, None; J. Triboulet, None; O. Bouche, None; P. Rougier, None; J. Bosset, None; T. Aparicio, None; F. Masskouri, None; L. Bedenne, None.
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A Phase II Study of Bevacizumab With Concurrent Capecitabine and Radiation Followed by Maintenance Gemcitabine and Bevacizumab for Locally Advanced Pancreatic Cancer: RTOG PA0411
C. H. Crane1, K. Winter2, W. Regine3, H. Safran4, T. Rich5, W. Curran6, R. Wolff1, C. Willett7 1 M.D. Anderson Cancer Center, Houston, TX, 2RTOG, Philadelphia, PA, 3University of Maryland, Baltimore, MD, 4Brown University, Providence, RI, 5University of Virginia, Charlottesville, VA, 6Thomas Jefferson University, Philadelphia, PA, 7Duke University, Durham, NC Purpose/Objective(s): The primary objective of this study was to assess the one-year overall survival of the combination of bevacizumab, capecitabine, and radiotherapy in patients with locally advanced, unresectable pancreatic cancer. Secondary endpoints included toxicity, objective response rate, and progression-free survival.
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