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• W1965970019 abstract "Purpose/Objective(s)To examine the safety/feasibility of a multi-center trial of combining concurrent chemotherapy and IMRT (CCRT) with BV followed by adjuvant chemotherapy with BV in the treatment of locally and/or regionally advanced NPC.Materials/MethodsPatients with NPC, WHO I-IIb/III, stage ≥T2b and/or + node(s) were eligible and prescribed concurrent BV (15mg/kg) and cisplatin (100mg/m2) on days 1, 22, 43 with IMRT to a total dose of 69.96 Gy over 33 fractions followed by adjuvant BV (15mg/kg), cisplatin(80mg/m2) on day 1 and fluorouracil (1000mg/m2/d) on days 1 through 4 for 3 cycles. The primary objective was to evaluate the safety/tolerability of BV and CCRT. Patients who underwent 3D-CRT were also eligible when the plan met the dose volume constraints per protocol.ResultsBetween December 2006 and February 2009, 46 patients were enrolled and 43 were analyzable. All but one patient underwent IMRT. Patients were predominantly male (65.1%), Asian (51.2%), Zubrod 0 (74.4%), and WHO IIb or III (72.1%), and with a median age of 48 years. Stages: T1 27.9%; T2a 7%; T2b 7%; T3 34.9%; T4 23.3%, N0 11.6%; N1 16.3%; N2 60.5%; N3a 4.7%; N3b 7%. Median dose delivered was 69.96 Gy (65.72 to 70). Percentages of patients receiving 3 cycles of cisplatin and BV during IMRT were 67.4% and 69.8% (1 patient had 4 cycles of cisplatin and BV) and those receiving 3 cycles of adjuvant cisplatin, fluorouracil, and BV were 44.2%, 51.2%, and 48.8%, respectively. No Grade 4 hemorrhage or Grade 5 adverse events were observed. Blood/bone marrow toxicity was the most common Grade 4 adverse event. The incidence of Grade 3 mucositis was 72.1% with only 1 patient experiencing Grade 4 toxicity while 53.5% of the patients experienced Grade 3 and none had Grade 4 dysphagia. Late grade 2 upper and lower gastrointestinal hemorrhage occurred in 1 patient 138 days from the start of RT. Toxicities are being reported with minimum follow-up of 1 year for all patients. Chemotherapy and radiation details will undergo central review and be presented at the meeting.ConclusionsIt was feasible to add BV to CCRT for locally and/or regionally advanced NPC with a compliance rate of 67.4%, which is slightly better than the Intergroup 0099 trial (63%) [although IMRT was not used] but lower than RTOG 0225 (87.7%). However, there was no difference in the compliance rate during the adjuvant phase of the treatment. No significant acute hemorrhage was observed with the addition of BV. Longer follow-up is needed to assess the efficacy and the late toxicities associated with this combination.This project was supported by RTOG grant(U10 CA21661), and CCOP grant(U10 CA37422) from the NCI. Purpose/Objective(s)To examine the safety/feasibility of a multi-center trial of combining concurrent chemotherapy and IMRT (CCRT) with BV followed by adjuvant chemotherapy with BV in the treatment of locally and/or regionally advanced NPC. To examine the safety/feasibility of a multi-center trial of combining concurrent chemotherapy and IMRT (CCRT) with BV followed by adjuvant chemotherapy with BV in the treatment of locally and/or regionally advanced NPC. Materials/MethodsPatients with NPC, WHO I-IIb/III, stage ≥T2b and/or + node(s) were eligible and prescribed concurrent BV (15mg/kg) and cisplatin (100mg/m2) on days 1, 22, 43 with IMRT to a total dose of 69.96 Gy over 33 fractions followed by adjuvant BV (15mg/kg), cisplatin(80mg/m2) on day 1 and fluorouracil (1000mg/m2/d) on days 1 through 4 for 3 cycles. The primary objective was to evaluate the safety/tolerability of BV and CCRT. Patients who underwent 3D-CRT were also eligible when the plan met the dose volume constraints per protocol. Patients with NPC, WHO I-IIb/III, stage ≥T2b and/or + node(s) were eligible and prescribed concurrent BV (15mg/kg) and cisplatin (100mg/m2) on days 1, 22, 43 with IMRT to a total dose of 69.96 Gy over 33 fractions followed by adjuvant BV (15mg/kg), cisplatin(80mg/m2) on day 1 and fluorouracil (1000mg/m2/d) on days 1 through 4 for 3 cycles. The primary objective was to evaluate the safety/tolerability of BV and CCRT. Patients who underwent 3D-CRT were also eligible when the plan met the dose volume constraints per protocol. ResultsBetween December 2006 and February 2009, 46 patients were enrolled and 43 were analyzable. All but one patient underwent IMRT. Patients were predominantly male (65.1%), Asian (51.2%), Zubrod 0 (74.4%), and WHO IIb or III (72.1%), and with a median age of 48 years. Stages: T1 27.9%; T2a 7%; T2b 7%; T3 34.9%; T4 23.3%, N0 11.6%; N1 16.3%; N2 60.5%; N3a 4.7%; N3b 7%. Median dose delivered was 69.96 Gy (65.72 to 70). Percentages of patients receiving 3 cycles of cisplatin and BV during IMRT were 67.4% and 69.8% (1 patient had 4 cycles of cisplatin and BV) and those receiving 3 cycles of adjuvant cisplatin, fluorouracil, and BV were 44.2%, 51.2%, and 48.8%, respectively. No Grade 4 hemorrhage or Grade 5 adverse events were observed. Blood/bone marrow toxicity was the most common Grade 4 adverse event. The incidence of Grade 3 mucositis was 72.1% with only 1 patient experiencing Grade 4 toxicity while 53.5% of the patients experienced Grade 3 and none had Grade 4 dysphagia. Late grade 2 upper and lower gastrointestinal hemorrhage occurred in 1 patient 138 days from the start of RT. Toxicities are being reported with minimum follow-up of 1 year for all patients. Chemotherapy and radiation details will undergo central review and be presented at the meeting. Between December 2006 and February 2009, 46 patients were enrolled and 43 were analyzable. All but one patient underwent IMRT. Patients were predominantly male (65.1%), Asian (51.2%), Zubrod 0 (74.4%), and WHO IIb or III (72.1%), and with a median age of 48 years. Stages: T1 27.9%; T2a 7%; T2b 7%; T3 34.9%; T4 23.3%, N0 11.6%; N1 16.3%; N2 60.5%; N3a 4.7%; N3b 7%. Median dose delivered was 69.96 Gy (65.72 to 70). Percentages of patients receiving 3 cycles of cisplatin and BV during IMRT were 67.4% and 69.8% (1 patient had 4 cycles of cisplatin and BV) and those receiving 3 cycles of adjuvant cisplatin, fluorouracil, and BV were 44.2%, 51.2%, and 48.8%, respectively. No Grade 4 hemorrhage or Grade 5 adverse events were observed. Blood/bone marrow toxicity was the most common Grade 4 adverse event. The incidence of Grade 3 mucositis was 72.1% with only 1 patient experiencing Grade 4 toxicity while 53.5% of the patients experienced Grade 3 and none had Grade 4 dysphagia. Late grade 2 upper and lower gastrointestinal hemorrhage occurred in 1 patient 138 days from the start of RT. Toxicities are being reported with minimum follow-up of 1 year for all patients. Chemotherapy and radiation details will undergo central review and be presented at the meeting. ConclusionsIt was feasible to add BV to CCRT for locally and/or regionally advanced NPC with a compliance rate of 67.4%, which is slightly better than the Intergroup 0099 trial (63%) [although IMRT was not used] but lower than RTOG 0225 (87.7%). However, there was no difference in the compliance rate during the adjuvant phase of the treatment. No significant acute hemorrhage was observed with the addition of BV. Longer follow-up is needed to assess the efficacy and the late toxicities associated with this combination.This project was supported by RTOG grant(U10 CA21661), and CCOP grant(U10 CA37422) from the NCI. It was feasible to add BV to CCRT for locally and/or regionally advanced NPC with a compliance rate of 67.4%, which is slightly better than the Intergroup 0099 trial (63%) [although IMRT was not used] but lower than RTOG 0225 (87.7%). However, there was no difference in the compliance rate during the adjuvant phase of the treatment. No significant acute hemorrhage was observed with the addition of BV. Longer follow-up is needed to assess the efficacy and the late toxicities associated with this combination." @default.
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• W1965970019 title "Phase II Study of Concurrent and Adjuvant Chemotherapy with Intensity Modulated Radiation Therapy (IMRT) or Three-dimensional Conformal Radiotherapy (3D-CRT) + Bevacizumab (BV) for Locally or Regionally Advanced Nasopharyngeal Cancer (NPC)[RTOG 0615]: Preliminary Toxicity Report" @default.
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