4 months (compared with 6.2 and 6.5 months in the E4599[4] and AVAiL[5] trials, respectively) and a median OS of 14.7 months (compared with 12.3 and >13 months in E4599 and AVAiL, respectively). In fact, the better comparator for our reported outcomes is the results of the SAiL phase IV trial,[8] since they reflect the experience of community
practice similar to that presented here, outside the rigidity of a phase III trial protocol. In the SAiL trial, the median OS was 14.6 months, which is very similar to our finding, and the time to tumor progression, which is usually longer than the PFS, was 7.8 months. Of note, the response rate observed in our study was higher than those in the phase III trials[4,5] discussed above. Of the patients in our series, 74.5% had some response, compared with 35% and 30.4% in E4599[4] and AVAiL,[5] respectively. One of the hypotheses for this difference is that responses were measured by the RECIST criteria in the phase III trials, find more whereas in our study, tumor assessments were carried out according to the treating physician’s ABT-263 order clinical practice. No specific requirements for assessment or confirmation of responses were implemented, which might have yielded higher responses rates in our study. The fact that the PFS in our study was much closer to those in the pivotal trials suggests that some responses captured in this study were temporary and did not see more impact final outcomes.
In the SAiL trial,[8] responses were likewise not measured using the RECIST guidelines, and response rates were also higher than in previous reports (the response rate in the SAiL trial was 51%). One particularly interesting finding in our study was that one patient who was presented as a complete response had a large lesion not initially considered for surgical resection, which developed into a cavitary lesion after four
cycles of platinum chemotherapy plus bevacizumab. Complete surgical resection was possible, and no residual tumor was detected in the pathology report, suggesting that bevacizumab can be considered as a neoadjuvant treatment in some situations.[12] Regarding identification of the best platinum doublet to use in association Cytidine deaminase with bevacizumab, our study did not favor any specific regimen. The most frequently used backbones were carboplatin plus paclitaxel or carboplatin plus pemetrexed. Interesting, the frequency of the association of carboplatin and paclitaxel reported in our study (62.5%) is very similar to the phase IV experience reported in the ARIES (Avastin Regimens: Investigation of Treatment Effects and Safety) study,[13] in which 64% of patients received carboplatin plus paclitaxel as the regimen of choice. A phase III trial[14] showed that pemetrexed added to cisplatin provided better outcomes in non-squamous NSCLC than gemcitabine/cisplatin. Although bevacizumab was approved for use in combination with carboplatin and paclitaxel,[6] this antibody is frequently added to other chemotherapy combinations.