scholarly journals Erlotinib and bevacizumab versus cisplatin, gemcitabine and bevacizumab in unselected nonsquamous nonsmall cell lung cancer

2015 ◽  
Vol 46 (1) ◽  
pp. 219-229 ◽  
Author(s):  
Michael Thomas ◽  
Jürgen Fischer ◽  
Stefan Andreas ◽  
Cornelius Kortsik ◽  
Christian Grah ◽  
...  

Erlotinib with bevacizumab showed promising activity in recurrent nonsquamous (NS) nonsmall cell lung cancer (NSCLC). The INNOVATIONS study was designed to assess in first-line treatment of unselected cisplatin-eligible patients this combination compared to cisplatin, gemcitabine and bevacizumab.Stage IIIB/IV patients with NS-NSCLC were randomised on erlotinib (150 mg daily) and bevacizumab (15 mg·kg−1 on day 1, every 3 weeks) (EB) until progression, or cisplatin (80 mg·m−2 on day 1, every 3 weeks) and gemcitabine (1250 mg·m−2 on days 1 and 8, every 3 weeks) up to six cycles and bevacizumab (15 mg·kg−1 on day 1, every 3 weeks) (PGB) until progression.224 patients were randomised (EB n=111, PGB n=113). The response rate (12% versus 36%; p<0.0001), progression-free survival (median 3.5 versus 6.9 months; hazard ratio (HR) 1.85, 95% CI 1.39–2.45; p<0.0001) and overall survival (median 12.6 versus 17.8 months; HR 1.41, 95% CI 1.01–1.97; p=0.04) clearly favoured PGB. In patients with epidermal growth factor receptor mutations (n=32), response rate, progression-free survival and overall survival were not superior with EB.Platinum-based combination chemotherapy remains the standard of care in first-line treatment of unselected NS-NSCLC. Molecular targeted approaches strongly mandate appropriate testing and patient selection.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 588-588
Author(s):  
M. Suenaga ◽  
N. Mizunuma ◽  
S. Matsusaka ◽  
E. Shinozaki ◽  
M. Ogura ◽  
...  

588 Background: Bevacizumab (BV) is a recombinant, humanized monoclonal antibody against vascular endothelial growth factor. Used in combination with chemotherapy, BV has been shown to improve survival in both first- and second-line treatment for metastatic colorectal cancer (mCRC). However, it was reported that addition of BV to FOLFOX conferred only little survival benefit (Saltz et al. JCO2008). The aim of this study was to assess the efficacy of addition of BV to FOLFOX in first-line treatment for patients with mCRC. Methods: Bevacizumab was approved for mCRC in July 2007 in Japan. This study was conducted at a single institution and comprised 217 consecutive patients receiving first-line treatment for mCRC between 2005 and 2009. The primary objective was to compare survival benefit in patients treated with FOLFOX4 (FF) between 2005 and 2007 with that in patients receiving FOLFOX4+BV 5 mg/kg (FF+BV) between 2007 and 2009. Results: Total number of patients in the FF and FF+BV groups was 132 and 85, respectively. Characteristics of patients were as follows (FF vs. FF+B): median age, 62 yrs (range 28-76 yrs) vs. 60 yrs (range16-74 yrs); ECOG PS0, 98.8% vs. 81.8%; and median follow-up time, 20.8 months vs. 24.4 months. Median progression-free survival (PFS) in the FF and FF+BV groups was 10 months (95% CI, 8.7-11.3) and 17 months (95% CI, 10.2-14.1), while median overall survival (OS) was 21 months (95% CI, 17.9-24.1) and not reached, respectively. Response rate was 46% (95% CI, 37- 54) in FF, and 62% (95% CI, 51-73) in FF+BV. Addition of BV to FOLFOX4 significantly improved PFS (p=0.002) and OS (p<0.001). Conclusions: The additive effect of BV for first-line FOLFOX was reconfirmed. These data indicate potential survival benefits from the addition of BV to FOLFOX in first-line treatment of mCRC. In addition, PFS may be a sensitive indicator of outcome prior to post-treatment. No significant financial relationships to disclose.


2007 ◽  
Vol 25 (36) ◽  
pp. 5777-5784 ◽  
Author(s):  
Charles A. Butts ◽  
David Bodkin ◽  
Edward L. Middleman ◽  
Craig W. Englund ◽  
David Ellison ◽  
...  

PurposeTo evaluate the efficacy of cetuximab added to first-line gemcitabine/platinum in chemotherapy-naïve patients with advanced non–small-cell lung cancer (NSCLC).Patients and MethodsIn this noncomparative, randomized trial, chemotherapy-naïve patients with recurrent/metastatic NSCLC (stage IV or stage IIIB with malignant pleural effusion) were eligible. Patients received cisplatin (75 mg/m2IV, every 3 weeks) or carboplatin (area under the concentration-versus-time curve of 5 intravenously [IV], every 3 weeks), and gemcitabine (1,250 or 1,000 mg/m2IV, days 1 and 8) plus cetuximab (400 mg/m2IV day 1, followed by 250 mg/m2weekly), in arm A, or chemotherapy alone, in arm B. Response rate was the primary end point; safety, progression-free survival, and overall survival were secondary end points.ResultsSixty-five patients were randomly assigned to arm A and 66 to arm B. Partial responses were observed in 18 patients (27.7%; 95% CI, 17.3 to 40.2) in arm A and 12 (18.2%; 95% CI, 9.8 to 29.6) in arm B. Median progression-free survival was 5.09 months for arm A (95% CI, 4.17 to 5.98) and 4.21 months (95% CI, 3.81 to 5.49) in arm B. Median overall survival was 11.99 months (95% CI, 8.80 to 15.18) and 9.26 months (95% CI, 7.43 to 11.79) in arms A and B, respectively. Overall toxicity was acceptable and consistent with the profiles of the individual agents.ConclusionFirst-line treatment with cetuximab plus gemcitabine/platinum is well tolerated and can be administered safely in patients with advanced NSCLC. Differences in response rate, progression-free survival, and overall survival suggest that the addition of cetuximab to platinum/gemcitabine may improve clinical outcomes. Larger studies are in progress to address this hypothesis.


2021 ◽  
pp. 53-53
Author(s):  
Sasa Jungic ◽  
Biljana Tubic ◽  
Jelena Berendika ◽  
Zdenka Gojkovic ◽  
Ivanka Rakita ◽  
...  

Background / Aim. FOLFOX (5fluorouracil, folinic acid, oxaliplatin)/CapOx (capecitabine, oxaliplatin) plus bevacizumab and FOLFIRI (5 fluorouracil, folinic acid, irinotecan) plus bevacizumab are a standard treatment options for a first line treatment of metastatic colorectal carcinoma (mCRC). The aim of this study was to compare overall response rate (ORR), progression-free survival (PFS) and overall survival (OS) in the groups of patients with mCRC who were treated in the first line with FOLFIRI/bev versus FOLFOX/bev. At the same time, it was compared the safety profile in observed groups of patients and investigated optimal treatment duration and characteristics of patients who had the best treatment outcomes. Methods. In a retrospective-prospective study, patients with mCRC were treated with a chemotherapy protocols for the first line in combination with bevacizumab (FOLFOX/bev, respectively, FOLFIRI/bev). Treatment efficacy was evaluated on the basis of overall response rate (ORR), progression-free survival (PFS) and overall survival (OS), and the safety of treatment was evaluated by monitoring adverse drug reactions. Results. ORR was 70% in the FOLFIRI/bev group and 50% in the FOLFOX/bev group. Median PFS for FOLFIRI/bev (n = 30) and for FOLFOX/bev (n = 30) was 15.6 months and 12.1 months respectively (HR, 0.85; 95% confidence interval (CI) 0.47-1.53; P = 0.5591). Median OS for FOLFIRI/bev and for FOLFOX/bev was 24.7 months and 19.9 months respectively (HR, 0.67; 95% confidence interval (CI) 0.37-1.23; P = 0.1552). In both patient groups, the patients who received more than 9 cycles of induction therapy had better treatment response in comparison with patients who received less than 9 cycles of therapy. In FOLFOX/bev group PFS was 16.9 versus 9.7 months and OS was 22.1 versus 17.6 months respectively. In FOLFIRI/bev group PFS was 9 months for patients who received less than 9 cycles of therapy versus 18.8 months for patients who received more than 9 cycles, OS was 18.0 versus 27.7 respectively. The adverse drug reactions grade 3 and 4 were 7% in the FOLFIRI/bev group versus 27% in the FOLFOX/bev group. Conclusion. Patients who received FOLFIRI/bev had better ORR (70 % versus 50 %), PFS (15.6 versus 12.1 months) and OS (24.7 versus 19.9 months). In both patient groups, better treatment response had the patients who received induction therapy for 4-6 months (more than 9 cycles of therapy).


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