Effects of diagnostic method and surgery on safety of first-line bevacizumab plus chemotherapy in advanced or recurrent non-squamous non-small cell lung cancer (NSCLC): MO19390 (SAiL)

Abstract

8058 Background: Safety data from the ongoing study of first-line bevacizumab (Bev) plus chemotherapy in patients (pts) with NSCLC (SAiL; MO19390) were analyzed to assess if the bleeding risk was affected by surgical procedure or diagnostic method. The latter, as a cytology-based diagnosis of NSCLC, may not reliably exclude squamous-cell type tumors. Methods: Pts with histologically and/or cytologically documented, locally advanced, metastatic non-squamous NSCLC and an ECOG PS of 0–2 receive open-label Bev plus standard first-line chemotherapy for up to 6 cycles followed by Bev alone until disease progression or unacceptable toxicity. Pts with a history of hemoptysis or evidence of either tumor invading major blood vessels or CNS mets are excluded (no baseline CNS scans). Results: Here we present preliminary data as documented in the EDC system (November 2007). 1065 pts (median age 60 years) have completed at least one cycle of treatment and are evaluable for safety. Diagnosis by cytology was not associated with higher bleeding risk (Table 1A). Incidence of bleeding complications in 190 pts who underwent surgery before and/or during the study was not increased compared with 875 without surgery (Table 1B). Only 4 pts undergoing surgery reported impaired healing or wound complication. Table 1A. Bleeding events by cytology/histology CTC ≥ grade 3/grade 5; B. Bleeding events for pts with/without surgery CTC ≥ grade 3/grade 5. Conclusions: This analysis suggests that there is no increased bleeding risk to date for pts diagnosed by cytology versus histology for Bev based therapy until progression and no increased risk associated with surgical procedures. The incidence of impaired wound healing was low. Updated results will be discussed. Table 1A Adverse event (≥ grade 3/ grade 5) Diagnostic method Cytology (n=309) Histology (n=608) Cytology + histology (n=99) Missing (n=49) n % n % n % n % Epistaxis 1/0 0.3/0 4/0 0.7/0 1/0 1.0/0 0/0 0/0 Hemoptysis 0/0 0/0 0/0 0/0 0/0 0/0 0/0 0/0 Other hemorrhage 1/1 0.3/0.3 3/0 0.5/0 3/1 3.0/1.0 0/0 0/0 Adverse event (≥ grade 3/ grade 5) Surgery before and/or during study (n=190) No surgery (n=875) n % n % Epistaxis 3/0 1.6/0 3/0 0.3/0 Hemoptysis 0/0 0/0 0/0 0/0 Other hemorrhage 3/0 1.6/0 4/2 0.5/0.2 Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Amgen, Roche, sanofi-aventis Roche Amgen, Roche, sanofi-aventis