Poster Session (Abstract 527)
First Author: Nita S. Nair, DNB, MRCS, MCh
When used as complementary therapy, yoga had a major benefit in fatigue, emotional function, and pain in women with operable, nonmetastatic breast cancer. The primary endpoint of the trial was the effect of yoga on disease-free survival; however, the therapy did not show a statistically significant difference in global quality of life (QOL) at the first interim analysis.
The trial randomly assigned patients to yoga and conventional exercise or to conventional exercise only in addition to standard therapy. Groups were balanced in both arms in terms of clinicopathologic factors. QOL was assessed using several measures: EORTC QLQC30, BR23, the Brief Fatigue Inventory, visual pain scores, and a spirituality questionnaire. These measures were assessed first at baseline and then at set points during the trial.
The first interim QOL analysis included 605 patients with at least 1 year of follow-up data. Although the analysis found no significant difference in QOL scores at 6 to 9 months, improvements were statistically significant for yoga participants in emotional function scores at 18 to 21 months, and these patients had fewer systemic side effects. The median scores for pain intensity, pain on movement, and pain on mobilization were lower for patients randomly assigned to yoga and conventional exercise.
Genitourinary (Nonprostate) Cancer
Poster Session (Abstract 4530)
First Author: Ronald De Wit, MD, PhD
Patients previously treated with platinum-based chemotherapy for advanced urothelial cancer who were randomly assigned to second-line therapy with pembrolizumab had substantially better health-related quality of life (HRQoL) for a longer duration than patients who were randomly assigned to chemotherapy in the KEYNOTE-045 trial.
The prespecified HRQoL analysis of KEYNOTE-045 included patients whose second-line therapy was either pembrolizumab 200 mg every 3 weeks or the investigator’s choice of paclitaxel, docetaxel, or vinflunine. Patients were administered the EORTC QLQ-C30 HRQoL instrument at cycles 1 to 4 and then every two cycles for up to 1 year and 30 days after discontinuation. The endpoints were change from baseline to week 15 and time to deterioration, defined as a 10-point or greater decrease from baseline in the global health status/QoL score.
At baseline, the global health status/QoL scores were similar between the trial arms; scores were stable at week 15 for the 266 patients in the pembrolizumab arm but worsened for the 254 patients treated with chemotherapy. At 15 weeks, patients without progressive disease had improved scores with pembrolizumab but worsening scores with chemotherapy. Patients treated with pembrolizumab had longer time to deterioration (hazard ratio 0.70, 95% CI [0.55, 0.90]; nominal one-sided p = 0.002).
Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Poster Session (Abstract 7036)
First Author: Jonathan E. Kolitz, MD
A new analysis of a randomized, open-label phase III trial of CPX-351 compared with 7 + 3 therapy indicated that some patients with high-risk acute myeloid leukemia (AML) can successfully receive CPX-351 consolidation therapy as outpatients without diminished efficacy. This suggests that the consolidation therapy could potentially reduce hospitalizations associated with treatment administration.
The trial, which included older patients (age 60 to 75) with newly diagnosed high-risk AML, demonstrated significantly improved overall survival (OS) with CPX-351 administered as a 90-minute infusion, compared with 7 + 3 administered as a continuous infusion.
This new analysis assessed efficacy in the setting of consolidation therapy. Forty-nine of the 153 patients who received induction therapy with CPX-351 and 32 of the 151 patients who received 7 + 3 induction therapy went on to receive consolidation therapy in either one or two cycles. Consolidation therapy with CPX-351 was associated with substantial improvement in median OS compared with 7 + 3, regardless of inpatient/outpatient status.
In the outpatient setting, median OS was 25.43 months for patients who received one cycle of consolidation therapy with CPX-351 compared with 6.87 months with 7 + 3 consolidation therapy (hazard ratio 0.10, 95% CI [0.01, 1.11]). With two consolidation cycles in the outpatient setting, median OS was 26.32 months with CPX-351 but was not reached with 7 + 3.