Phase II study of chemoradiation plus bevacizumab (BV) for locally/regionally advanced nasopharyngeal carcinoma (NPC): Preliminary clinical results of RTOG 0615.

Authors

null

N. Y. Lee

Memorial Sloan-Kettering Cancer Center, New York, NY

N. Y. Lee , Q. E. Zhang , A. S. Garden , J. J. Kim , D. G. Pfister , J. Mechalakos , K. Hu , Q. Le , B. S. Glisson , A. T. C. Chan , K. K. Ang

Organizations

Memorial Sloan-Kettering Cancer Center, New York, NY, RTOG Statistical Center, Philadelphia, PA, University of Texas M. D. Anderson Cancer Center, Houston, TX, Princess Margaret Hospital, Toronto, ON, Canada, Beth Israel Medical Center, New York, NY, Stanford University Medical Center, Stanford, CA, M. D. Anderson Cancer Center, Houston, TX, Sir YK Pao Center for Cancer, Hong Kong Cancer Institute and Li Ka Shing Institute for Health Sciences, CUHK, Shatin, Hong Kong

Research Funding

NIH

Background: To present progression-free survival (PFS), overall survival (OS), distant metastases-free (DMF), loco-regional progression-free (LRPF), and toxicity rates of chemotherapy, IMRT and BV for NPC. Methods: Patients with NPC, WHO I-IIb/III, stage ≥T2b and/or + node(s) were given concurrent 3 cycles of BV (15mg/kg) and cisplatin (CDDP; 100mg/m2) with IMRT (70Gy) followed by 3 cycles of adjuvant BV (15mg/kg), CDDP (80mg/m2) and fluorouracil (1,000mg/m2/d) q3 weeks. Results: From 12/06 to 2/09, 44 patients enrolled and eligible for analysis. Patients were male (65.9%), Asian (52.3%), Zubrod 0 (75%), and WHO IIb or III (72.7%) with a median age of 48.5 years. Stages: T1 27.3%; T2a 9.1%; T2b 6.8%; T3 34.1%; T4 22.7%; N0 11.4%; N1 18.2%; N2 59.1%; N3a 4.5%; N3b 6.8%; IIB 11.4%; III 54.5%; IVA 22.7%; IVB 11.4%. Median dose was 70 Gy. Percentages of patients receiving 3 cycles of CDDP and BV during IMRT were 68.2% and 70.5% while 47.7%, 54.5%, and 52.3% received 3 cycles of adjuvant CDDP, fluorouracil, and BV, respectively. Median follow-up for surviving patients was 2.0 years (1.0-3.1). The 2-year PFS and OS were 71.7% and 90.9%, respectively. Five patients experienced DM with 2-year DMF rate of 90.8%. Nine patients experienced LR failures with 2-year LRPF rate of 80.7%. The apparently lower LR control might be related to attribution we applied in unclear cases, i.e., death from study cancer or unknown causes without documented progression are considered LR failure (n=3). No Grade 3-4 hemorrhage or Grade 5 toxicity was observed. Blood/bone marrow toxicity was the most common Grade 4 toxicity and 77.3% experienced Grade 3-4 mucositis. Conclusions: The combination of chemotherapy, IMRT and BV in treating NPC was feasible in a multi-institutional setting. When comparing RTOG 0615 vs RTOG 0225 and Intergroup 0099, the preliminary findings reveal similar PFS but favor RTOG 0615 for OS. These preliminary findings seemed to suggest that BV prolongs OS by slowing down the progression of disease in those not cured with chemoradiation. However, the findings from these comparisons will need to be confirmed in a randomized setting, preferably in patients at high risk for DM.

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Abstract Details

Meeting

2011 ASCO Annual Meeting

Session Type

Poster Discussion Session

Session Title

Head and Neck Cancer

Track

Head and Neck Cancer

Sub Track

Head and Neck Cancer

Clinical Trial Registration Number

RTOG0615

Citation

J Clin Oncol 29: 2011 (suppl; abstr 5516)

Abstract #

5516

Poster Bd #

10

Abstract Disclosures