LBA3500^ Background: Therapy targeting VEGF or EGFR demonstrated clinical activity in combination with chemotherapy (CT) in mCRC but monoclonal antibodies cannot be associated. The DREAM trial compares a maintenance therapy (MT) with bev +/- EGFR tyrosine kinase inhibitor erlotinib (E) after a first-line Bev-based induction therapy (IT) in pts with mCRC. Methods: Pts with previously untreated and unresectable mCRC were eligible. After a Bev-based IT with FOLFOX or XELOX or FOLFIRI, pts without disease progression were randomized to MT between Bev alone (Bev 7.5 mg/kg q3w; arm A) or Bev+E (B 7.5 mg/kg q3w, E 150 mg/day continuously; arm B). Pts were treated until progression or unacceptable toxicity. The primary endpoint was PFS on MT. Results: The study enrolled 700 pts from 01/2007 to 11/2011 in 3 countries (France, Canada, Austria). 446 (63.7%) pts were randomized for MT (arm A, N=224; arm B, N=222). Among the 446 randomized pts, IT regimen was FOLFOX-Bev in 265 pts (59.4%), XELOX-Bev in 135 pts (30.3%), and FOLFIRI-Bev in 46 pts (10.3%). Baseline characteristics of randomized pts were (arm A/B): ECOG PS 0, 60% in both arms; normal LDH level 47%/49%; normal alkaline phosphatase level 48%/50%; synchronous metastasis 83%/82%. The median no of MT cycles was 6 in both arms. With a median follow-up of 31.0 months, 327 PFS events were observed. Median MT-PFS were 4.6 m in arm A vs 5.8 m in arm B (HR 0.73 [95%CI: 0.59-0.91], P=.005). Median PFS from inclusion were 9.2 m vs 10.2 m. During MT, in arm A vs arm B, grade 3-4 diarrhea (<1% vs 9%) and grade 3 skin toxicity (0% vs 19%) were the main differences in toxicity. Severe adverse events from randomization related to B or E were 6 in arm A and 7 in arm B. Overall survival is not mature. Conclusions: The addition of erlotinib to bevacizumab after induction therapy significantly improves the duration of maintenance PFS, following induction with first-line chemotherapy plus bevacizumab, in patients with unresectable metastatic colorectal cancer.
248 Background: Efficacy and safety of a combination chemotherapy regimen consisting of oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) is one of the gold standard in metastatic pancreatic cancer as first-line therapy for patients with PS 0-1, good haematological and renal function and a subnormal bilirubin level. Pending approval, this treatment has been allowed in Brittany (B) and Pays de la Loire (PL) respecting these criteria. Methods: Observatory of Cancer B/PL is a network of 50 private/public cancer centers focused on good practice for cancer drugs use. Our aim is to evaluate the use of FOLFIRINOX between July 2010 and June 2013 in B/PL. Sex, age, successive chemotherapeutic regimens, toxicities, response rate, progression free survival (PFS) and overall survival (OS) have been studied. Results: Data of 79 patients, treated in 2010 (37%), in 2011 (54%) or early 2012 (9%) have been studied (44 men, median age 62 years [37-74]). 64 patients were metastatic when cancer was diagnosed. Principal site of metastases was liver (73%). 17 primary tumors were resected and 15 patients received an adjuvant chemotherapy (gemcitabine (n=14)).The median number of treatment cycles was 9 [1-24]. Objective response was observed in 29 patients (37%), disease stabilization in 18 patients (23%) and progression in 18 patients (23%). During treatment, 75% of patients had a dose adjustment and 30 % had one or more dose delays. 22 patients presented grade III/IV toxicity (almost neurotoxicity or haematologic). 42 patients had a second line of treatment (mainly gemcitabine) and 7 patients a third line. The median PFS and OS were respectively 174 days IC95% [125-216] and 309 days IC 95% [229-376]. Conclusions: Our preliminary results are relatively convenient with those of Conroy et al in 2011. A higher rate of response (37% vs 32%) has been found. Concerning PFS and OS, our results are clearly worst with 174 vs 195 days and 309 vs 338 days. Our results confirm the aggressiveness of this schedule with 75% of the patients requiring a dose adjustement. Analysis of all pancreatic metastatic patients treated by FOLFIRINOX in B/PL by the Observatory of Cancer allows to assess its good use in the real life.
305 Background: FOLFIRINOX, one of the gold standard in metastatic pancreatic cancer as first-line therapy for patients under 76 years with PS 0-1, good haematological and renal function and a subnormal bilirubin level (Prodige 4 criteria), was analysed in Brittany (B) and Pays de la Loire (PL) in routine clinical practice. Methods: Our aim is to evaluate the use of Folfirinox between July 2010 and December 2012 in B/PL. Results: Data of 340 patients have been studied (198 men, median age 63 years [29-81]). 208 patients were metastatic at diagnosis (liver 67%). 62 primary tumors were resected and 51 patients had received previous adjuvant chemotherapy (gemcitabine, n=48). The median progression free survival PFS and overall survival OS were respectively 6.80 months IC95% [6.18-7.43] and 10.97 months IC 95% [9.56-11.83]. Patients could be divided into 4 groups : Group 1 composed of patients treated according to Prodige 4 trial (n=242), Group 2 1st line metastatic patients with at least one Prodige 4 non-eligibility criterion (n=25), Group 3 locally advanced patients (n=59) and Group 4 by Folfirinox in 2ndline (n=14). The median number of cycles was 9 [1-27] in Group 1 and 6 [1-12] in Group 2. Clinical benefit was 65% (group 1) vs 56% (group 2). During treatment, 81% of patients had a dose adjustment (Group 1) vs 72% (Group 2) and 32% vs 40% presented grade III/IV toxicity (mostly neuro- or haematotoxicity). Median PFS were respectively in Group 1 vs Group 2 : 6.54 months IC95% [5.98-7.29] vs 4.14 [1.68-6.21] (p=0.0107) and median OS :10.91 months IC 95% [8.94-12.02] vs 7.0 IC95% [4.01-11.20] (p=0.0166). For Group 3 and 4, median OS were respectively 11.24 months [10.0-15.01] vs 11.50 [4.83-14.09]. Others results will be shown at the meeting. For Group 1, stopping treatment before progression induced significatively better median PFS and OS than going on treatment until progression : PFS : 8.25 IC95[7.52-8.74] vs 3.48. IC95 [3.09-4.44] (p<0.0001) and OS : 12.78 months IC95 [11.60-15.54] vs 7.62 IC95 [6.44-9.49] (p<0.0001). Conclusions: Our results for Group 1 are relatively consistent with those of Prodige 4: objective response rate (39% vs 32%), PFS (6.5 vs 6.4 months) and OS (10.9 vs 11.1 months). Non eligibity for Prodige 4’s criteria decreases PFS and OS significantly.
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