Everolimus for Previously Treated Advanced Gastric Cancer: Results of the Randomized, Double-Blind, Phase III GRANITE-1 Study
Why is this work in the frame?
A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.
No Canadian affiliation. An affiliation-only frame — the usual design — would never have seen this work. It is one of the works that make the case for inverting the frame.
Machine scores (provisional)
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
- Teacher spread
- 0.348 · how far apart the two teachers sit on this one work
- Validation status
score_only:v0-immature-baseline· verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it
Abstract
PURPOSE: The oral mammalian target of rapamycin inhibitor everolimus demonstrated promising efficacy in a phase II study of pretreated advanced gastric cancer. This international, double-blind, phase III study compared everolimus efficacy and safety with that of best supportive care (BSC) in previously treated advanced gastric cancer. PATIENTS AND METHODS: Patients with advanced gastric cancer that progressed after one or two lines of systemic chemotherapy were randomly assigned to everolimus 10 mg/d (assignment schedule: 2:1) or matching placebo, both given with BSC. Randomization was stratified by previous chemotherapy lines (one v two) and region (Asia v rest of the world [ROW]). Treatment continued until disease progression or intolerable toxicity. Primary end point was overall survival (OS). Secondary end points included progression-free survival (PFS), overall response rate, and safety. RESULTS: Six hundred fifty-six patients (median age, 62.0 years; 73.6% male) were enrolled. Median OS was 5.4 months with everolimus and 4.3 months with placebo (hazard ratio, 0.90; 95% CI, 0.75 to 1.08; P = .124). Median PFS was 1.7 months and 1.4 months in the everolimus and placebo arms, respectively (hazard ratio, 0.66; 95% CI, 0.56 to 0.78). Common grade 3/4 adverse events included anemia, decreased appetite, and fatigue. The safety profile was similar in patients enrolled in Asia versus ROW. CONCLUSION: Compared with BSC, everolimus did not significantly improve overall survival for advanced gastric cancer that progressed after one or two lines of previous systemic chemotherapy. The safety profile observed for everolimus was consistent with that observed for everolimus in other cancers.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
The record
- Venue
- Journal of Clinical Oncology
- Topic
- Gastric Cancer Management and Outcomes
- Field
- Medicine
- Canadian institutions
- —
- Funders
- West China Hospital, Sichuan UniversityBC Cancer AgencyNovartis PharmaChugai PharmaceuticalRuijin HospitalHebei Medical UniversityNanfang HospitalInstitut Gustave-RoussySchool of Medicine, Shanghai Jiao Tong UniversityPeking UniversityKU LeuvenSichuan UniversityUniversitair Ziekenhuis GentSun Yat-sen UniversityChina Medical UniversityFudan UniversityMcGill UniversitySir Run Run Shaw HospitalShanghai Jiao Tong UniversityHarbin Medical UniversitySanofiSoochow UniversityGlaxoSmithKline
- Keywords
- EverolimusMedicineRamucirumabInternal medicineHazard ratioClinical endpointAdverse effectCancerPlaceboPhases of clinical researchGastroenterologyChemotherapySurgeryOncologyClinical trialConfidence intervalPathology
- Has abstract in OpenAlex
- yes