Topotecan was compared with pegylated liposomal doxorubicin in a randomized trial of 474 patients and demonstrated similar response rates, PFS, and OS at the time of the initial report.
Pentostatin given intravenously every other week for 3 to 6 months produces a 50% to 76% complete response rate and an 80% to 87% overall response rate.
A randomized, phase III trial of 571 patients designed to demonstrate the noninferiority of pemetrexed compared with docetaxel showed no difference in response rates, PFS, or OS.
In a previous trial, similar patients treated with a combination of trastuzumab, capecitabine, and cisplatin(but not bevacizumab) had an overall survival of 13.8 months and a 47% response rate.
Efficacy outcome measures included confirmed overall response rate(as assessed by blinded independent central review using RECIST v1.1 and modified RECIST for HCC) and duration of response..
The primary endpoint in CheckMate -275 trial is objective response rate, and additional efficacy measures included durability of response and overall survival.
Patients with 2 or 3 risk factors treated with CPX-351 had rates of response and 60-day death rates that were similar to those with only 0 or 1 risk factor.
In January 2006, Sutent(sunitinib) received accelerated approval based on durable response rate, or tumor size reduction, and was later demonstrated to delay tumor progression.
The secondary endpoints of the study were PFS(at 6 months and 12 months), objective response rate(ORR), and time to deterioration in Quality of Life Global Health Status/Quality of Life Scales of the European Organization for Research and Treatment of Cancer(EORTC) Quality of Life Questionnaire.
Patients receiving the combination with the higher dose of ipilimumab had the highest objective response rate(38.5%), which is confirmed complete response(disappearance of tumors) plus confirmed partial response(at least a 30% shrinkage of tumors).
Among these patients, overall response rate(ORR) was 48 percent(95% CI: 42%, 55%) and importantly, 57 percent had previous treatment with more than one ALK TKI.
Another study demonstrated significant responses to olaparib in recurrent ovarian cancer patients, including patients with a BRCA1/BRCA2 pathogenic variant(objective response rate[ORR], 41%) and patients without a BRCA1/BRCA2 pathogenic variant(ORR, 24%).
In the KRAS wild-type tumor population, there was a statistically significant improvement in response rate(61% vs. 37%, P= .011) and PFS(7.7 months vs. 7.2 months, P= .0163).
A randomized comparison of second-line treatment with either cyclophosphamide, doxorubicin, and vincristine(CAV) or topotecan in patients with sensitive disease reported no significant difference in response rates or survival, but palliation of common lung cancer symptoms was better with topotecan.
The secondary endpoints were PFS(at six months and 12 months), objective response rate(ORR) and time to deterioration in the Quality of Life Global Health Status/Quality of Life Scales of the European Organization for Research and Treatment of Cancer(EORTC) Quality of Life Questionnaire and Safety.
Additionally, at 30 months, the objective response rate(ORR) per investigator for intermediate- and poor-risk patients with Opdivo plus low-dose Yervoy improved compared to the previous analysis at a minimum of 17.5 months.
The analysis for the combination also showed median progression-free survival(PFS) of 11.0 months, overall response rate(ORR) of 69%, and median duration of response(DoR) of 12.9 months[1].
The evaluation for the response rate(tumor reduction effect) on 21 subjects*2 as of 90 days after the completion of the trials has been completed, and it has been confirmed that the anticipated results were achieved.
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