Early treatment discontinuation and switching in first-line metastatic breast cancer: the role of patient-reported symptom burden.

Treatment options for metastatic breast cancer (MBC) are complex, and some patients experience early discontinuation or switching of treatment (ETDS). We examined the relationship between ETDS and patient-reported symptom burden among patients receiving first-line treatment of MBC in community oncology settings. This retrospective observational study used the ACORN Data Warehouse, a comprehensive community oncology repository of medical records and patient-reported outcomes. Patients with first-line treatment for MBC who had Patient Care Monitor (PCM) surveys were eligible. ETDS was defined as: record stating ETDS, treatment duration < planned, and planned therapy <6 weeks. Symptom burden was measured by two PCM composite scores [continuous (0-22) and categorical (absent, mild, moderate, and severe)] computed from 22 PCM items with varying cut points to assess symptom burden over time. Cox regression with time-varying covariates was used to assess risk for ETDS controlling for patient characteristics and treatment type: chemo (chemotherapy without targeted therapy (±hormone therapy); targeted (chemotherapy plus targeted therapy (±hormone therapy); and hormone (hormone therapy only). Overall, 197 (24.7 %) of a total sample of 797 patients had an ETDS event, of which 109 (55.3 %) were switches rather than early discontinuation. ETDS rate was nominally lower in the hormone group (11.1 %) versus chemo (27.6 %) or targeted (26.1 %). PCM continuous composite score predicted ETDS, controlling for other variables (HR = 1.132, p < 0.0001). ETDS was predicted by moderate and severe levels of PCM categorical composite score (HR = 4.135, and HR = 5.287 vs. absent, respectively, both p < 0.0001), with the pattern suggesting a threshold effect. Moderate or severe levels of a wide range of patient-reported symptoms and the accumulation of symptoms over time significantly predicted ETDS. Providers may better maintain patients on planned therapy if they attend to overall symptom burden patients experience over time.

Treatment patterns and outcomes among patients with metastatic melanoma treated in community practice.

BACKGROUND: The primary systemic treatments for advanced melanoma have been chemotherapy and immunotherapy. New agents are currently in development. OBJECTIVES: This study aimed to characterize treatment patterns and outcomes across several lines of therapy and to illustrate the treatment landscape prior to the approval of new therapies. The study endpoints were progression-free survival (PFS), overall survival (OS), and best overall response within line of therapy. METHODS: A retrospective chart analysis was conducted at 11 community oncology practices in the USA. Data for patients aged ≥18 years and diagnosed with stage IV and/or metastatic melanoma during 2006-2010 were analyzed. Primary endpoints were PFS within line of therapy and OS from the diagnosis of metastasis. RESULTS: Data on a total of 202 patients were collected. The sample was mostly male (60%) and Caucasian (88%), with a mean age of 61.3 years. Of the 202 patients, 56 (28%) never received any systemic therapy. In the remaining 146 patients, systemic therapies included temozolomide-based regimens (n = 68), platinum-based regimens without temozolomide (n = 16), other regimens (n = 23), and research regimens (n = 39). Of the 146 patients who received systemic therapy, not all did so immediately after the diagnosis of metastasis: 102 (51%) patients did so shortly after diagnosis and before first disease progression, and 44 (22%) did so after first disease progression. Response rates were very low (≤5%) and did not differ across treatment groups. Progressive disease was the most frequent best overall response category identified, with rates of 83, 78, and 89% in the first to third lines of treatment, respectively. In 146 patients receiving first-line systemic therapy, median PFS was 3.25 months. Median OS in the entire sample was 7.66 months. CONCLUSIONS: Findings provided little evidence for any beneficial effects of the treatments available in the timeframe referred to in this study. Few patients (≤5%) responded to treatment, PFS among treated patients was short (3.25 months in first-line treatments, less in later lines), and there was no evidence of a differential effect of treatment regimens on PFS. There was no evidence of shorter survival in patients who never received systemic therapy. The high proportion of patients who did not receive any systemic therapy highlights the lack of effective therapies and underscores the unmet medical need in this patient population.

Symptom burden & quality of life among patients receiving second-line treatment of metastatic colorectal cancer.

BACKGROUND: Bevacizumab (B) and cetuximab (C) are both approved for use in the treatment of metastatic colorectal cancer (mCRC) in the second-line. We examined patient reported symptom burden during second-line treatment of mCRC. METHODS: Adult mCRC patients treated in the second-line setting with a regimen that included B, C, or chemotherapy only (O) and who had completed ≥ 1 Patient Care Monitor (PCM) surveys as part of routine clinical care were drawn from the ACORN Data Warehouse. Primary endpoints were rash, dry skin, itching, nail changes, nausea, vomiting, fatigue, burning in hands/feet, and diarrhea. Linear mixed models examined change in PCM scores across B, C and O (B = reference). RESULTS: 182 patients were enrolled (B: n = 106, C: n = 38, O: n = 38). Patients were 51% female, 67% Caucasian, with mean age of 62.0 (SD = 12.6). Groups did not differ on demographic or clinical characteristics. The most common second-line regimens were FOLFIRI ± B or C (23.1%) and FOLFOX ± B or C (22.5%). Results showed baseline scores to be strongly predictive of second-line symptoms across all PCM items (all p's < .0001 except for Rash, p = .0013). Controlling for baseline, patients on B tended to have more stable and less severe symptoms. Patients on C had more severe rash, dry skin, and itching and had nail change scores that worsened faster than did B patients. CONCLUSIONS: Patients receiving second-line treatment for mCRC with B report less symptom burden, especially dermatologic, compared to patients treated with C.