The TC regimen achieved comparable efficacy to the PT regimen but was associated with better tolerability and quality of life, and should, therefore, be considered as an important alternative for standard first-line chemotherapy in patients with advanced ovarian cancer.
Gemcitabine plus carboplatin significantly improves PFS and response rate without worsening quality of life for patients with platinum-sensitive recurrent ovarian cancer.
BackgroundOverall survival (OS) can be observed only after prolonged follow-up, and any potential effect of first-line therapies on OS may be confounded by the effects of subsequent therapy. We investigated whether tumor response, disease control, progression-free survival (PFS), or time to progression (TTP) could be considered a valid surrogate for OS to assess the benefits of first-line therapies for patients with metastatic breast cancer.
Patients and MethodsIndividual patient data were collected on 3,953 patients in 11 randomized trials that compared an anthracycline (alone or in combination) with a taxane (alone or in combination with an anthracycline). Surrogacy was assessed through the correlation between the end points as well as through the correlation between the treatment effects on the end points.
ResultsTumor response (survival odds ratio [OR], 6.2; CI, 5.3 to 7.0) and disease control (survival OR, 5.5; CI, 4.8 to 6.3) were strongly associated with OS. PFS (rank correlation coefficient [], 0.688; CI, 0.686 to 0.690) and TTP (, 0.682; CI, 0.680 to 0.684) were moderately associated with OS. Response log ORs were strongly correlated with PFS log hazard ratios (, 0.96; CI, 0.73 to 1.19). Response and disease control log ORs and PFS and TTP log hazard ratios were poorly correlated with log hazard ratios for OS, but the confidence limits of were too wide to be informative.
ConclusionNo end point could be demonstrated as a good surrogate for OS in these trials. Tumor response may be an acceptable surrogate for PFS.J Clin Oncol 26:000-000.
This study confirms that capecitabine achieves a high tumor control rate in heavily pretreated patients with metastatic breast cancer. Due to its favorable safety profile and convenient oral administration, capecitabine can be given as an outpatient therapy. Capecitabine should be considered the reference treatment in this setting based on consistently high efficacy and good tolerability.
Gefitinib monotherapy at 500 mg daily did not appear to be efficacious in the treatment of heavily pretreated metastatic breast cancer patients. It was well tolerated and the side effect profile was as expected from current knowledge of the drug. There was no correlation between EGFR expression and response in this study.
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