Background

In oncology, quality of life (QoL) questionnaires were historically designed to be used in the advanced or metastatic setting. We sought to determine the effects of contemporary treatments on QoL in the adjuvant setting and to determine if the QoL instruments used in these studies provide a relevant assessment.

Methods

We conducted a systematic identification of all anti-cancer drugs used in the adjuvant setting and approved by the US Food and Drug Administration from January 2018 to March 2022. We conducted a quality evaluation and a meta-analysis of reported QoL results. We used the global QoL results when multiple QoL outcomes were reported.

Results

There were 224 FDA approvals reviewed, of which 12 met the inclusion criteria. The placebo was the control arm in 10 out of 12 trials. Of those, 11 trials (92 %) assessed QoL, and ten (83 %) reported results. In reports with QoL results, a moderate-risk of bias was found in 3 out of 10 (30 %) and a high-risk of bias in 6 out of 10 (60 %) of reports, respectively. No trial reported a meaningful difference between arms. The meta-analysis found an overall detrimental effect on QoL in the experimental arm, though it was not statistically different.

Conclusion

This study identified 12 FDA registration trials in the adjuvant setting between 2018 and 2022. We found a moderate- to high-risk of bias in 90 % of the ten trials reporting QoL data. Our meta-analysis suggested a detrimental effect on QoL in the experimental arm, questioning the relevancy, in the adjuvant setting, of thresholds that were mostly developed in the advanced or metastatic setting.

Policy summary

Future works should focus on specificities of the adjuvant setting when considering QoL evaluation.

PURPOSE: Compared with people living without HIV (PWOH), people living with HIV (PWH) and cancer have traditionally been excluded from immune checkpoint inhibitor (ICI) trials. Furthermore, there is a paucity of real-world data on the use of ICIs in PWH and cancer. METHODS: This retrospective study included PWH treated with anti-PD-1- or anti-PD-L1-based therapies for advanced cancers. Kaplan-Meier method was used to estimate overall survival (OS) and progression-free survival (PFS). Objective response rates (ORRs) were measured per RECIST 1.1 or other tumor-specific criteria, whenever feasible. Restricted mean survival time (RMST) was used to compare OS and PFS between matched PWH and PWOH with metastatic NSCLC (mNSCLC). RESULTS: Among 390 PWH, median age was 58 years, 85% (n = 331) were males, 36% (n = 138) were Black; 70% (n = 274) received anti-PD-1/anti-PD-L1 monotherapy. Most common cancers were NSCLC (28%, n = 111), hepatocellular carcinoma ([HCC]; 11%, n = 44), and head and neck squamous cell carcinoma (HNSCC; 10%, n = 39). Seventy percent (152/216) had CD4+ T cell counts ≥200 cells/µL, and 94% (179/190) had HIV viral load <400 copies/mL. Twenty percent (79/390) had any grade immune-related adverse events (irAEs) and 7.7% (30/390) had grade ≥3 irAEs. ORRs were 69% (nonmelanoma skin cancer), 31% (NSCLC), 16% (HCC), and 11% (HNSCC). In the matched mNSCLC cohort (61 PWH v 110 PWOH), 20% (12/61) PWH and 22% (24/110) PWOH had irAEs. Adjusted 42-month RMST difference was -0.06 months (95% CI, -5.49 to 5.37; P = .98) for PFS and 2.23 months (95% CI, -4.02 to 8.48; P = .48) for OS. CONCLUSION: Among PWH, ICIs demonstrated differential activity across cancer types with no excess toxicity. Safety and activity of ICIs were similar between matched cohorts of PWH and PWOH with mNSCLC.