Treatment patterns of patients with HR+/HER2- metastatic breast cancer receiving CDK4/6 inhibitor-based regimens: a cohort study in the French nationwide healthcare database.

PURPOSE: To assess real-world treatment patterns in patients diagnosed with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer (mBC) who received cyclin-dependent kinase 4/6 (CDK4/6) inhibitors in combination with an aromatase inhibitor (AI) or fulvestrant at first line. METHODS: Patient characteristics, treatment history, and outcomes data were extracted from the French 'Système National des Données de Santé' (SNDS) database for patients diagnosed with HR+/HER2- mBC between January 2014 and June 2019 and who received combination therapy with a CDK4/6 inhibitor and endocrine therapy. Kaplan-Meier methodology was used to assess time to next treatment (TTNT) and time to treatment discontinuation (TTTD). RESULTS: The cohort comprised 6061 patients including 4032 patients who received CDK4/6 inhibitors + AIs and 2029 patients who received CDK4/6 inhibitors + fulvestrant. Median follow-up was 13.5 months (IQR 9.5-18.1). The median TTTD of first line treatment with CDK4/6 inhibitors + AIs and CDK4/6 inhibitors + fulvestrant was 17.3 months (95% CI 16.8-17.9) and 9.7 months (95% CI 9.0-10.2), respectively. Chemotherapy was the most common second line therapy. Median TTTD of subsequent treatment lines was progressively shorter following first line treatment with CDK4/6 inhibitors + AIs (2nd line: 4.6 months (95% CI 4.4-4.9) and with CDK4/6 inhibitors + fulvestrant (2nd line: 4.7 months (95% CI 4.3-5.1). TTNT was longer than TTTD across lines of therapy. CONCLUSION: This real-world analysis confirms the effectiveness of CDK4/6 inhibitor-based regimens in French patients and highlights the frequent use of chemotherapy as second line therapy.

Feasibility, acceptability and preferences for intraperitoneal chemotherapy with paclitaxel and cisplatin after optimal debulking surgery for ovarian and related cancers: an ANZGOG study.

OBJECTIVE: Intraperitoneal (IP) chemotherapy in women with optimally debulked stage III ovarian cancer has been reported to prolong overall survival, but has not been widely adopted due to concerns about its toxicity, inconvenience and acceptability to patients. The purposes of this study were to determine the regimen's feasibility, adverse events, catheter-related complications, progression-free survival, health-related quality of life (HRQL), and patients' preferences for IP versus intravenous (IV) chemotherapy. METHODS: We conducted a single arm, multi-center study of IP chemotherapy with IV paclitaxel 135 mg/m(2) (D1) over 3 hours, IP cisplatin 75 mg/m(2) (D2), and IP paclitaxel 60 mg/m(2) (D8) for 6 cycles in women with optimally debulked stage III ovarian or related cancers. RESULTS: Thirty-eight eligible patients were recruited from 12 sites between July 2007 and December 2009. Seventy-one percent (n=27) completed at least 4 cycles and 63% (n=24) completed all 6 cycles. Grade 3 or 4 adverse events included nausea (n=2), vomiting (n=2), abdominal pain (n=2), and diarrhea (n=1), but not febrile neutropenia, neurotoxicity, or nephropathy. There were no treatment-related deaths. Catheter-related complications were the most frequent cause of early discontinuation of treatment (16 patients, 21%). Apart from neurotoxicity HRQL which worsened over time, HRQL was stable or improved with time. Most patients (≥50%) judged moderate benefits (e.g., an extra 6 months survival time or a 5% improvement in survival rates) necessary to make IP chemotherapy worthwhile. CONCLUSION: IP chemotherapy was feasible, tolerable, and most participants considered moderate survival benefits sufficient to warrant the adverse effects and inconvenience.

Symptom control in patients with recurrent ovarian cancer: measuring the benefit of palliative chemotherapy in women with platinum refractory/resistant ovarian cancer.

Most women with advanced ovarian cancer will relapse and subsequently develop platinum-resistant/refractory ovarian cancer. The benefit of treatment is currently based on objective response rates, which are a crude measure of benefit. It would be clinically meaningful if we were better able to measure the benefit of palliative therapy and, in particular, ascertain whether cancer-related symptoms improve with treatment and how this impacts on quality of life. This paper reviews the management of patients with platinum-resistant/refractory ovarian cancer and highlights the gaps in our knowledge and shortcomings with the current approaches to measure the benefit of treatment. The ultimate objective is to describe and encourage recruitment to the Gynecologic Cancer Intergroup study that has recently opened. This study will recruit a large number of patients from around the world in an effort to develop more robust instruments to measure the benefit of chemotherapy and to understand the impact of chemotherapy on symptom control and quality of life. In addition, this study will give us an insight into how all patients are managed rather than a select minority who are treated in clinical trials.

Outcomes of surveillance mammography after treatment of primary breast cancer: a population-based case series.

GOAL: To ascertain outcomes of surveillance mammography (SM) following treatment of early stage unilateral primary breast cancer (PBC) in a population based case series. METHODS: Random samples from all 12,279 women having breast surgery within 4 months after diagnosis of PBC, between July 1991 and December 1993 in Ontario, were drawn from a database created by deterministic linkage of PBC files from the Ontario Cancer Registry (OCR) with episodes of breast surgery extracted from the hospital Discharge Abstract Database (DAD), and mammography from the Ontario physician billings database (OHIP). Among women having >or=1 episode(s) of breast surgery subsequent (SBS) to the date of diagnosis up to December 2000, a sample of 1,200/5,064 (23.7%) was drawn, and among women with no SBS, a sample of 400/7,215 (5.5%). Among these two samples, operative, pathology, and mammography reports were abstracted from original charts. Treatments were abstracted and categorized. Women with complete data for Stages 1 and 2 unilateral PBC were included. From the subsequent surgery sample, 609/1,200 (50.8%) were excluded because of simultaneous or sequential bilateral breast cancers or mastectomies within 6 months, missing stage information, Stage 3 or 4 PBC, or missing primary charts. From the no subsequent surgery sample, 90/400 (22.5%) were excluded by the same criteria. Episodes of bilateral 2-view X-ray mammography, beginning >or=6 months after the diagnosis of unilateral PBC, and if multiple, at least 11 months apart, and not prompted by a clinical concern or symptom, were classified as SM. We confirmed episodes of cancer recurrence within the ipsilateral conserved breast (CRICB) and metachronous contralateral primary breast cancer (CPBC) >or=6 months after the diagnosis of the unilateral PBC from original operative and pathology reports. We used Cox models to describe the association of exposure to >or=1 episode(s) of SM with the risk of death from breast cancer among the study population, and separately among women experiencing CRICB or CPBC. RESULTS: Eligible women comprising 591/1,200 and 310/400 produced a combined case series of 901/1,600 (56.3%). Women with >or=1 episode(s) of SM numbered 721/901 (80.0%). We confirmed 84 CRICB events among 584 women initially treated by lumpectomy (14.4%), and 49 CPBC events among all 901 women in the study population (5.4%). Among women having >or=1 episode(s), the 25th percentile of observed follow up was 1,631 days, the 50th, 4,287 days, and the 75th 5,011 days. Among women without any SM, the 25th percentile of observed follow-up was 440 days, the 50th, 891 days, and the 75th, 1,849 days. Hazard ratio (HR) for death due to breast cancer associated with >or=1 episode of SM was 0.28 (95% CI 0.22-0.37), adjusted for age, stage, type of surgery, adjuvant chemotherapy, and tamoxifen. Among 84/584 women with CRICB, unadjusted HR = 0.36 (95%CI 0.13, 1.00) and among 49/901 women with CPBC, unadjusted HR = 0.86 (0.20-3.77). CONCLUSION: SM was associated with a significant reduction in the hazard for breast cancer death. Among women who experienced CRICB, the reduction was of borderline significance, and the reduction was not significant among women who experienced CPBC.