A prospective observational study of patient-reported functioning and quality of life in advanced and metastatic breast cancer utilizing a novel mobile application.

PURPOSE: To assess and describe patient-reported outcomes (PROs) in women with locally advanced/unresectable or metastatic breast cancer (aBC/mBC) with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR + /HER2 -) status receiving palbociclib combination therapy in a US real-world setting. METHODS: A prospective, noninterventional, multicenter longitudinal study was conducted in US patients initiating treatment with palbociclib combination therapy for HR + /HER2 - aBC/mBC. PRO data (SF-12; CES-D-10; mood; pain; fatigue; interference of aBC/mBC or its treatment on family life, social life, physical activity, energy, and productivity; overall health rating; and quality of life [QOL]) were collected via a custom-developed mobile application at daily, weekly, and cycle-based intervals. Patient medical information (demographics, clinical characteristics, treatment information, and adverse events) was collected from medical records at baseline and at the end of the 6-month follow-up period. RESULTS: Patients' general health status (SF-12) remained consistent throughout treatment and was generally consistent with published norms for individuals diagnosed with cancer. The presence of depression (CES-D-10) was low and did not change substantially over time. Mean pain and fatigue scores using an 11-point numeric rating scale were low and remained stable. Patients, on average, reported neutral or positive moods. Patient-reported QOL and overall health was primarily "Good," "Very good," or "Excellent." Findings were consistent regardless of patient experience with neutropenia. CONCLUSIONS: Patients treated with palbociclib, on average, reported consistently low levels of pain and fatigue as well as good QOL and overall health that remained stable throughout the first 6 months of treatment regardless of episodes of neutropenia.

Resumption of menses with initiation of letrozole after five years of amenorrhea on tamoxifen: caution needed when using tamoxifen followed by aromatase inhibitors.

BACKGROUND: Randomized trials in postmenopausal women have shown a benefit to substituting aromatase inhibitors for tamoxifen or using them sequentially following a full course of tamoxifen. The aromatase inhibitor letrozole has also been utilized for ovarian induction in premenopausal women. CASE REPORT: A premenopausal woman with early stage breast cancer became amenorrheic with adjuvant chemotherapy, and remained so during 5 years of daily tamoxifen. After discontinuing tamoxifen, laboratory studies confirmed an apparent postmenopausal state. Menses resumed following a 2-week course of letrozole. CONCLUSION: Aromatase inhibitors need to be used with caution in women who stop menstruating following adjuvant chemotherapy or tamoxifen.

Compassionate-use oxaliplatin with bolus 5-fluorouracil/leucovorin in heavily pretreated patients with advanced colorectal cancer.

OBJECTIVES: The efficacy of a concomitant oxaliplatin/bolus 5-fluorouracil/leucovorin regimen in 123 heavily pretreated patients with advanced colorectal cancer was evaluated. Patients with an Eastern Cooperative Oncology Group performance status of 0 to 2 and radiographically progressive cancer which failed to respond to between two and five prior treatment modalities were consented and enrolled. METHODS: Patients received oxaliplatin on day 1 of weeks 1, 3, and 5 of an 8-week cycle. 5-fluorouracil/leucovorin was administered on day 1 of weeks 1 through 6. RESULTS: Grade 3 to 4 toxicities were as follows: diarrhea 30%; vomiting 11%; hematologic < 3%; peripheral neuropathy 2.5%. Of the 101 patients evaluable for response, 7% achieved a partial response (median duration 4.25 mo), 1 patient achieved a minor response (7 mo), and 31% had stable disease (median duration 6.08 mo). The median time to progression was 3.6 months. CONCLUSION: This regimen in heavily pretreated patients with disseminated colorectal cancer is of modest benefit, often at the expense of considerable gastrointestinal toxicity. It appears that the use of oxaliplatin/bolus 5-fluorouracil/leucovorin is more toxic than oxaliplatin/infusional 5-fluorouracil and possibly less effective.