PURPOSE: The study objective was to determine the proportion of patients with hepatocellular carcinoma (HCC) treated with the combination of bevacizumab (B) and erlotinib (E) who were alive and progression free at 16 weeks (16-week progression-free survival [PFS16]) of continuous therapy. Secondary objectives included response rate, median PFS, survival, and toxicity. PATIENTS AND METHODS: Patients who had advanced HCC that was not amenable to surgical or regional therapies, up to one prior systemic treatment; Childs-Pugh score A or B liver function; Eastern Cooperative Oncology Group performance status 0, 1, or 2 received B 10 mg/kg every 14 days and E 150 mg orally daily, continuously, for 28-day cycles. Tumor response was evaluated every 2 cycles by using Response Evaluation Criteria in Solid Tumors Group criteria. A total of 40 patients were treated. RESULTS: The primary end point of PFS16 was 62.5%. Ten patients achieved a partial response for a confirmed overall response rate (intent-to-treat) of 25%. The median PFSevent was 39 weeks (95% CI, 26 to 45 weeks; 9.0 months), and the median overall survival was 68 weeks (95% CI, 48 to 78 weeks; 15.65 months). Grades 3 to 4 drug-related toxicity included fatigue (n = 8; 20%), hypertension (n = 6; 15%), diarrhea (n = 4; 10%) elevated transaminases (n = 4; 10%), gastrointestinal hemorrhage (n = 5; 12.5%), wound infection (n = 2; 5%) thrombocytopenia (n = 1; 2.5%), and proteinuria, hyperbilirubinemia, back pain, hyperkalemia, and anorexia (n = 1 each). CONCLUSION: The combination of B + E in patients who had advanced HCC showed significant, clinically meaningful antitumor activity. B + E warrant additional evaluation in randomized controlled trials.
PURPOSE: The study objective was to determine the proportion of patients with hepatocellular carcinoma (HCC) treated with the combination of bevacizumab (B) and erlotinib (E) who were alive and progression free at 16 weeks (16-week progression-free survival [PFS16]) of continuous therapy. Secondary objectives included response rate, median PFS, survival, and toxicity. PATIENTS AND METHODS: Patients who had advanced HCC that was not amenable to surgical or regional therapies, up to one prior systemic treatment; Childs-Pugh score A or B liver function; Eastern Cooperative Oncology Group performance status 0, 1, or 2 received B 10 mg/kg every 14 days and E 150 mg orally daily, continuously, for 28-day cycles. Tumor response was evaluated every 2 cycles by using Response Evaluation Criteria in Solid Tumors Group criteria. A total of 40 patients were treated. RESULTS: The primary end point of PFS16 was 62.5%. Ten patients achieved a partial response for a confirmed overall response rate (intent-to-treat) of 25%. The median PFSevent was 39 weeks (95% CI, 26 to 45 weeks; 9.0 months), and the median overall survival was 68 weeks (95% CI, 48 to 78 weeks; 15.65 months). Grades 3 to 4 drug-related toxicity included fatigue (n = 8; 20%), hypertension (n = 6; 15%), diarrhea (n = 4; 10%) elevated transaminases (n = 4; 10%), gastrointestinal hemorrhage (n = 5; 12.5%), wound infection (n = 2; 5%) thrombocytopenia (n = 1; 2.5%), and proteinuria, hyperbilirubinemia, back pain, hyperkalemia, and anorexia (n = 1 each). CONCLUSION: The combination of B + E in patients who had advanced HCC showed significant, clinically meaningful antitumor activity. B + E warrant additional evaluation in randomized controlled trials.
Authors: Sam J Lubner; Michelle R Mahoney; Jill L Kolesar; Noelle K Loconte; George P Kim; Henry C Pitot; Philip A Philip; Joel Picus; Wei-Peng Yong; Lisa Horvath; Guy Van Hazel; Charles E Erlichman; Kyle D Holen Journal: J Clin Oncol Date: 2010-06-07 Impact factor: 44.544
Authors: L V Klotz; M E Eichhorn; B Schwarz; H Seeliger; M K Angele; K-W Jauch; Christiane J Bruns Journal: Langenbecks Arch Surg Date: 2012-03-14 Impact factor: 3.445
Authors: Philip A Philip; Michelle R Mahoney; Kyle D Holen; Donald W Northfelt; Henry C Pitot; Joel Picus; Patrick J Flynn; Charles Erlichman Journal: Cancer Date: 2011-09-27 Impact factor: 6.860
Authors: Robert J Lewandowski; Mary F Mulcahy; Laura M Kulik; Ahsun Riaz; Robert K Ryu; Talia B Baker; Saad M Ibrahim; Michael I Abecassis; Frank H Miller; Kent T Sato; Seanthan Senthilnathan; Scott A Resnick; Edward Wang; Ramona Gupta; Richard Chen; Steven B Newman; Howard B Chrisman; Albert A Nemcek; Robert L Vogelzang; Reed A Omary; Al B Benson; Riad Salem Journal: Radiology Date: 2010-06 Impact factor: 11.105
Authors: Ahmed O Kaseb; Manal M Hassan; E Lin; Lianchun Xiao; Vikas Kumar; Priyanka Pathak; Richard Lozano; Asif Rashid; James L Abbruzzese; Jeffrey S Morris Journal: Cancer Date: 2010-12-14 Impact factor: 6.860