Avid Bioservices Inc (CDMO)

[mojojojo]

pharmboy,

You said:

Now, as I understand, the chemo and bavi were not stopped at the same time. Chemo was up to 6 cycles (4.2 months), likely based on tolerability, and bavi was continued for as long as disease progression (? months) did not occur. Meaning that there could still be patients receiving bavi many months after having stopped the chemo.

I could be wrong but my understanding is that patients get a one week rest period between cycles. That would be 5.5 months for six cycles. The results from this avastin NSCLC trial correlate to that time frame. Irregardless, bavi's PFS of 6.5 months is similar to avastin's 6.2 months. The median number of treatment cycles in the avastin trial was seven. This was most likely six cycles of chemo/avastin and just one additional cycle of avastin as a mono therapy.

Treatment

The median number of cycles of therapy was five in the paclitaxel–carboplatin group and seven in the paclitaxel–carboplatin–bevacizumab group (including the cycles of bevacizumab monotherapy). Of the 407 patients starting treatment with paclitaxel and carboplatin plus bevacizumab for whom we had adequate information on the duration of treatment, 215 (53%) continued with bevacizumab monotherapy, and of these, 107 (50%) received more than five cycles of monotherapy. Information on treatment at the time of disease progression was available for 528 of the 850 patients included in the primary analysis. Chemotherapy was given to 200 patients in the paclitaxel–carboplatin group (including 87 of 180 women [48%]) at the time of disease progression, as compared with 180 patients in the paclitaxel–carboplatin–bevacizumab group (82 of 207 women [40%]). In addition, more women in the paclitaxel–carboplatin group received second-line chemotherapy: 48% (87 of 180) as compared with 40% (82 of 207) in the paclitaxel–carboplatin–bevacizumab group. However, there was no significant difference in the number of women who subsequently received epidermal growth factor–tyrosine kinase inhibitors (32 of 180 in the paclitaxel–carboplatin group and 34 of 207 in the paclitaxel–carboplatin–bevacizumab group).

Efficacy Analysis

The median overall survival was 12.3 months in the paclitaxel–carboplatin–bevacizumab group, as compared with 10.3 months in the paclitaxel–carboplatin group (hazard ratio for death, 0.79; 95% CI, 0.67 to 0.92; P=0.003) (Figure 2A). Survival rates were 51% in the paclitaxel–carboplatin–bevacizumab group, as compared with 44% in the paclitaxel–carboplatin group, at 1 year and 23%, as compared with 15%, respectively, at 2 years. The median progression-free survival was also significantly improved in the paclitaxel–carboplatin–bevacizumab group (6.2 months, as compared with 4.5 in the paclitaxel–carboplatin group), for a hazard ratio for disease progression of 0.66 (95% CI, 0.57 to 0.77; P<0.001) (Figure 2B). Among 773 patients with measurable disease, the addition of bevacizumab to paclitaxel and carboplatin improved the response rate; 59 of 392 patients (15%) in the paclitaxel–carboplatin group had a response, as compared with 133 of 381 patients (35%) in the paclitaxel–carboplatin–bevacizumab group (P<0.001).

http://content.nejm.org/cgi/content/full/355/24/2542