Entry Detail
| General information | |
| Database: | DB00507 |
| Objective: | The perception that older cancer patients may be at higher risk than younger patients of toxic effects from cancer therapy but may obtain less clinical benefit from it may be based on the underrepresentation of older patients in clinical trials and the known toxic effects of cytotoxic chemotherapy. It is not known how older patients respond to targeted therapy. |
| Authors: | Eisen T, et al |
| Title: | Sorafenib for older patients with renal cell carcinoma: subset analysis from a randomized trial. |
| Journal: | J Natl Cancer Inst. |
| Year: | 2008 |
| PMID: | 18840822 |
| Trial Design | |
| Clinical Trial Id: | NA |
| Agent: | sorafenib |
| Target: | Vascular endothelial growth factor receptor 1 BRaf protooncogene serine/threonineprotein kinase Protooncogene tyrosineprotein kinase receptor ret |
| Cancer Type: | renal cell carcinoma |
| Cancer Subtype: | advanced renal cell carcinoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a retrospective analysis |
| Key Patients Feature: | The study population in TARGET consisted of patients who wereat least 18 years of age with histologically confirmed metastaticrenal cell carcinoma. Patients with disease progression after theyreceived at least one systemic treatment for metastatic renal cellcarcinoma (within the previous 8 months) were enrolled in thestudy. Other eligibility criteria included Eastern CooperativeOncology Group performance status of 0 or 1; a Memorial SloanKettering Cancer Center prognostic score indicating low or intermediate risk; and adequate bone marrow, liver, pancreatic, andrenal function |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | older (age >or=70 years, n = 115) and younger patients (age <70 years, n = 787) |
| Treatment Info: | NA |
| Primary End Point: | Best tumor response, clinical benefit rate, time to selfreported health status deterioration, and toxic effects |
| Secondary End Point: | NA |
| Patients Number: | 902 |
| Trial Results | |
| DLT_MTD: | The most common adverse events that were observed in at least10% of sorafenibtreated patients are shown in Table 4 . Olderpatients had slightly more gastrointestinal symptoms than youngerpatients; younger patients had a higher incidence of sorafenibrelatedhypertension, sensory neuropathy, and pruritus than didolder patients. More older patients than younger patients experiencedfatigue. |
| Objective Response Rate: | Among 381 younger patients randomlyassigned to receive sorafenib, 33 (8.7%) had a partial response and285 (74%) had stable disease. Among younger patients randomlyassigned to receive placebo, six (1.5%) had a partial response and213 (52%) had stable disease. Among the 70 older sorafenibtreatedpatients, one (1.4%) had a complete response, 10 (14%) had a partialresponse, and 48 (69%) had stable disease Amongolder patients who were randomly assigned to receive placebo, two(4.4%) had partial response and 26 (58%) had stable disease |
| Disease Control Rate: | in youger patients group, sorafenib vs placebo: 83.5% vs 53.8%; in older patients group, sorafenib vs placebo: 84.3% vs 62.2% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | Median progression free survival was similar in sorafenibtreated younger patients (23.9 weeks; hazard ratio [HR] for progression compared with placebo = 0.55, 95% confidence interval [CI] = 0.47 to 0.66) and older patients (26.3 weeks; HR = 0.43, 95% CI = 0.26 to 0.69). |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | The overall incidence of adverse events of any grade among younger sorafenibtreated patients was 94.2%, among older sorafenibtreated patients was 98.6%, among younger placebotreated patients was 85.7%, .The most frequently reported adverse events among older sorafenibtreated patients were rash or desquamation, diarrhea, alopecia, fatigue, hand-foot skin reaction, and anorexia. among older placebotreated patients was 86.7%. |
| Conclusions: | Among patients with advanced renal cell carcinoma receiving sorafenib treatment, outcomes of older (or=70 years) and younger (70 years) patients were similar. |