Poor Well-Being Scores Linked to Early Treatment Stoppage in Multiple Myeloma

Among patients being treated for multiple myeloma (MM), a potential link was found between worse score on the Functional Assessment of Cancer Therapy-General General Physical Wellbeing Scale (GP5) and early treatment discontinuation (ETD), according to the results of a new analysis published online today with JAMA Network Open. Investigators used the scale to gauge patient self-reported treatment tolerability, with implications of predicting both this outcome and ETD risk among patients.

“Patient-reported outcome measures capture multiple concepts relevant to evaluation of cancer treatments, including health-related quality of life, disease symptoms, and adverse effects of treatment,” the investigators wrote. “This interest reflects a shift away from using clinician-assessed adverse events as the sole approach to determining if a treatment is tolerable.”

Their secondary analysis involved 1058 patients with a new MM diagnosis participating in the phase 3 parallel E1A11 trial (ENDURANCE; NCT01863550), which was conducted in February and April 2023; their mean (SD) age was 64 (9) years, and most reported a White ethnicity (82%). In this trial, patients were randomized to either bortezomib (Velcade) and lenalidomide (Revlimid)/dexamethasone (VRd) induction therapy (n = 531) or carfilzomib (Kyprolis) and lenalidomide/dexamethasone (KRd) induction therapy (n = 527). The GP5 was administered at baseline and 1, 2.8, and 5.5 months after treatment initiation, with patients being able to choose from 1 of 5 responses to the statement, “I am bothered by side effects of treatment”—very much, quite a bit, somewhat, a little bit, and not at all—and their change from baseline classified as worsening by 1 or 2 or more response categories.

Patient feedback on how they feel during MM treatment may be a useful tool to complement other clinical data | Image Credit: fizkes - stock.adobe.com

Most patients had a baseline Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 1 (48.2%) or 0 (42.7%) and International Staging System stage I disease (37.3%). The top 3 reasons given for ETD were alternative therapy (15.9%), AEs (13.4%), and patient withdrawal/refusal (5.6%).

At baseline, the most common GP5 response was “a little bit,” in 8.7%. The next most common response was “quite a bit” in 5.9%. Most patients reported “not at all” for baseline bother level, per the GP5, but with each evaluation, this group decreased substantially.

The most common maximum GP5 responses during treatment were “somewhat” among 34.4% and “a little bit” in 27.8%. For baseline-adjusted maximum GP5 during treatment, again, “somewhat” in 30.6% and “a little bit” in 23.7%.

Considering the 1-, 2.8-, and 5.5-month evaluations, the following results were seen:

• At 1 month, 26.2% reported worsening by 2 or more categories, 29.6% by 1 category, and 44.2% reported improvement/stayed the same
• At 2.8 months, 32% reported worsening by 2 or more categories, 31.1% by 1 category, and 36.9% reported improvement/stayed the same
• At 5.5 months, 28.5% reported worsening by 2 or more categories, 33.7% by 1 category, and 37.5% reported improvement/stayed the same

Close to half of the patients (48.7%) reported a change from baseline to maximum GP5 of worsening by 2 or more categories compared with 29% who reported worsening by 1 category and 22.3% who stayed the same or reported improvement.

Using logistic regression models, the study authors also saw higher odds of ETD in several categories:

• At 5.5 and 2.8 months, those who reported a high vs a low level of bother on the GP5 while undergoing treatment had unadjusted and adjusted ORs of 4.55 (95% CI, 1.75-11.84) and 4.66 (95% CI, 1.69-12.83), respectively
• From baseline to 1 month, reporting worsening by 2 or more categories vs staying the same/improving had unadjusted and adjusted ORs of 1.38 (95% CI, 0.88-2.16) and 1.42 (95% CI, 0.89-2.77)
• From baseline to 2.8 months, reporting worsening by 2 or more categories vs staying the same/improving had unadjusted and adjusted ORs of 3.17 (95% CI, 1.76-5.71) and 3.02 (95% CI, 1.64-5.14)
• From baseline to 5.5 months, reporting worsening by 2 or more categories vs staying the same/improving had unadjusted and adjusted ORs of 5.36 (95% CI, 1.49-19.31) and 5.49 (95% CI, 1.45-20.76)

Their overall conclusion was that the GP5 was an accurate indicator of patient intolerability of cancer treatment and due to its concise length, is “a low-burden way to track treatment tolerability over time, both in the context of clinical trials and in routine care.” They also echo the opinions of the FDA and previous reports, noting that GP5 can complement measures considered more traditional when calculating treatment tolerability, such as Common Terminology Criteria for Adverse Events, dose reductions, and hospitalization rates.

Reference

Peipert JD, Zhao F, Lee JW, et al. Patient-reported adverse events and early treatment discontinuation among patients with multiple myeloma. JAMA Netw Open. Published online March 27, 2024. doi:10.1001/jamanetworkopen.2024.3854