scholarly journals Efficacy and safety of palbociclib and ribociclib in patients with estrogen and/or progesterone receptor positive, HER2 receptor negative metastatic breast cancer in routine clinical practice

PLoS ONE ◽  
2021 ◽  
Vol 16 (7) ◽  
pp. e0253722
Author(s):  
Sushmita Rath ◽  
Prahalad Elamarthi ◽  
Pallavi Parab ◽  
Seema Gulia ◽  
Ravindra Nandhana ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Progesterone Receptor ◽  
Metastatic Breast ◽  
Routine Clinical Practice ◽  
Line Treatment ◽  
Efficacy And Safety ◽  
First Line ◽  
Cox Regression Analysis ◽  
Line Setting

Background There is scant data from India on efficacy and safety of palbociclib and ribociclib in routine clinical practice. Methods This retrospective, observational, single institution study included patients with estrogen and/or progesterone receptor positive and human epidermal growth factor receptor 2 (HER2) negative metastatic breast cancers, who received palbociclib or ribociclib with any partner endocrine therapy in any line of treatment between January 2016 and June 2019. Data were analyzed for progression-free survival (PFS), overall survival (OS) and toxicity. Results The study included 101 female patients with median age of 57 (IQR 48–62) years, of whom 80 (79.2%) were postmenopausal, 79 (78.2%) received palbociclib or ribociclib in second- or later-line treatment, 59 (58.4%) received fulvestrant and 41 (40.6%) received an aromatase inhibitor. In first-line treatment, at a median follow-up of 21.7 (0.5–41.9) months, median PFS and OS were 21.1 (95%CI 16.36-not estimable) months and not reached, respectively. In second- or later-line setting, at a median follow-up of 17.2 (0.5–43.7) months, median PFS and OS were 5.98 (95%CI 4.96–7.89) months and 20.2 (95%CI 14.1-not estimable) months, respectively. Grade 3–4 neutropenia and febrile neutropenia were seen in 45 (45.0%) and 9 (9.0%) patients, respectively while dose reduction was required in 32 (31.7%) patients. In multivariable Cox regression analysis, first-line setting (HR 0.49, 95%CI 0.25–0.97, p = 0.043) and ECOG performance status 1 (HR 0.43, 95%CI 0.20–0.91, p = 0.028) were significantly associated with PFS while only ECOG PS 1 was significantly associated (HR 0.04, 95%CI 0.008–0.206, p = 0.000) with OS. Conclusion Palbociclib and ribociclib, when used in routine clinical practice in first or subsequent lines of treatment, resulted in efficacy and toxicity outcomes in concordance with those expected from pivotal trials.

scholarly journals Comparative effectiveness of first-line palbociclib plus letrozole versus letrozole alone for HR+/HER2− metastatic breast cancer in US real-world clinical practice

2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Angela DeMichele ◽  
Massimo Cristofanilli ◽  
Adam Brufsky ◽  
Xianchen Liu ◽  
Jack Mardekian ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Clinical Practice ◽  
Real World ◽  
Metastatic Breast ◽  
Routine Clinical Practice ◽  
Survival Outcomes ◽  
First Line ◽  
Line Setting

Abstract Background Findings from randomized clinical trials may have limited generalizability to patients treated in routine clinical practice. This study examined the effectiveness of first-line palbociclib plus letrozole versus letrozole alone on survival outcomes in patients with hormone receptor–positive (HR+)/human epidermal growth factor receptor–negative (HER2−) metastatic breast cancer (MBC) treated in routine clinical practice in the USA. Patients and methods This was a retrospective observational analysis of electronic health records within the Flatiron Health Analytic Database. A total of 1430 patients with ≥ 3 months of follow-up received palbociclib plus letrozole or letrozole alone in the first-line setting between February 3, 2015, and February 28, 2019. Stabilized inverse probability treatment weighting (sIPTW) was used to balance baseline demographic and clinical characteristics. Real-world progression-free survival (rwPFS) and overall survival (OS) were analyzed. Results After sIPTW adjustment, median follow-up was 24.2 months (interquartile range [IQR], 14.2–34.9) in the palbociclib group and 23.3 months (IQR, 12.7–34.3) in those taking letrozole alone. Palbociclib combination treatment was associated with significantly longer median rwPFS compared to letrozole alone (20.0 vs 11.9 months; hazard ratio [HR], 0.58; 95% CI, 0.49–0.69; P < 0.0001). Median OS was not reached in the palbociclib group and was 43.1 months with letrozole alone (HR, 0.66; 95% CI, 0.53–0.82; P = 0.0002). The 2-year OS rate was 78.3% in the palbociclib group and 68.0% with letrozole alone. A propensity score matching analysis showed similar results. Conclusions In this “real-world” population of patients with HR+/HER2− MBC, palbociclib in combination with endocrine therapy was associated with improved survival outcomes compared with patients treated with letrozole alone in the first-line setting. Trial registration Clinicaltrials.gov; NCT04176354

scholarly journals Lactate Dehydrogenase (LDH) Response to First-Line Treatment Predicts Survival in Metastatic Breast Cancer: First Clues for A Cost-Effective and Dynamic Biomarker

Cancers ◽  
2019 ◽  
Vol 11 (9) ◽  
pp. 1243 ◽  
Author(s):  
Giacomo Pelizzari ◽  
Debora Basile ◽  
Silvia Zago ◽  
Camilla Lisanti ◽  
Michele Bartoletti ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Lactate Dehydrogenase ◽  
Prognostic Factor ◽  
Metastatic Breast ◽  
Prognostic Impact ◽  
Line Treatment ◽  
First Line ◽  
Cox Regression Analysis ◽  
First Line Treatment

Background: Elevated plasmatic lactate dehydrogenase (LDH) levels are associated with worse prognosis in various malignancies, including metastatic breast cancer (MBC). Nevertheless, no data are available on the prognostic role of LDH as a dynamic biomarker during first-line treatment in unselected MBC. Methods: We reviewed data of 392 women with MBC to evaluate the association between LDH variation after 12 weeks of first-line treatment and survival. The prognostic impact was tested by multivariate Cox regression analysis. Results: Plasmatic LDH was confirmed as an independent prognostic factor in MBC. Patients who maintained elevated LDH levels after 12 weeks of first-line treatment experienced worse progression-free survival (PFS, HR 2.88, 95% CI: 1.40–5.89, p = 0.0038) and overall survival (OS, HR 2.61, 95% CI 1.16–5.86, p = 0.02) compared to patients with stable normal LDH levels, even after adjustment for other prognostic factors. Notably, LDH low-to-high variation emerged as an unfavorable prognostic factor for PFS (HR 3.96, 95% CI 2.00–7.82, p = 0.0001). Conclusions: Plasmatic LDH and its variation during first-line treatment predict PFS and OS in MBC, providing independent prognostic information. It would be worthwhile to prospectively evaluate the association between LDH variation and therapeutic benefit in MBC, and explore how it may affect treatment strategies.

A review of the patterns of docetaxel use for hormone refractory prostate cancer (HRPC) at the Princess Margaret Hospital

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e16161-e16161
Author(s):  
S. N. Chin ◽  
L. Wang ◽  
A. Lau ◽  
M. Moore ◽  
S. S. Sridhar
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Median Duration ◽  
Response Rates ◽  
Routine Clinical Practice ◽  
Phase Iii ◽  
Line Treatment ◽  
Second Line ◽  
First Line

e16161 Background: Docetaxel is standard of care for the treatment of HRPC, based on two large randomized clinical trials. The aim of this study was to determine if docetaxel use and effectiveness in routine clinical practice was similar to that seen in the TAX 327 randomized phase III clinical trial. Methods: A retrospective chart review was undertaken to assess patterns of docetaxel use for HRPC at our institution for the 2-year period since its approval for the first-line treatment of HRPC in 2005. Results: Eighty-eight patients, median age 71 and baseline PSA 107, received docetaxel in the first line setting. Main reasons for initiating docetaxel were rising PSA (90%) and progressive symptoms (71%). Eighteen percent of patients received docetaxel for rising PSA alone. A median of 7 cycles was administered. PSA response rates were 61%, time to response 1.5 months, and response duration 6.8 months. Disease progression was the most common reason for treatment discontinuation (36%). Main toxicities were fatigue (32%) and neuropathy (22%). Kaplan Meier survival analysis showed median duration of survival was 15.9 months (95% CI 12.4–20.5) from first drug use. 1-year survival was 0.63 (95% CI 0.52–0.72). Post-docetaxel, 36 patients received second-line treatment, mostly with mitoxantrone (89%). Second-line response rates were 22%, and median duration of response was 4 months. Conclusions: In routine clinical practice, docetaxel is a well-tolerated regimen for the treatment of HRPC. Response rates and toxicity profiles were comparable to the randomized trials. However, compared with the TAX 327 clinical trial, survival was slightly shorter than expected (15.9 vs. 18.9 months), possibly due to inclusion of patients with poorer performance status and comorbidities, who may be excluded from clinical trials. Second-line response rates were also comparable with previous reports. No significant financial relationships to disclose.

Generic imatinib therapy among Jordanians: An observational assessment of safety and efficacy in routine clinical practice.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18548-e18548
Author(s):  
Abdallah Awidi ◽  
Salah Y. Abbasi ◽  
Kamal Hosni Al-Rabi ◽  
Khalid Kheirallah
Keyword(s):  
Clinical Practice ◽  
Middle Eastern ◽  
Primary Objective ◽  
Routine Clinical Practice ◽  
Imatinib Therapy ◽  
Efficacy And Safety ◽  
Observational Assessment ◽  
First Line ◽  
Optimal Response ◽  
Prospective Study Design

e18548 Background: Generic imatinib therapy is being globally considered due to cost considerations. Evidence about its efficacy and safety in developing country settings, however, is scarce. Methods: The efficacy and safety of generic imatinib among Jordanian patients diagnosed with chronic myeloid leukemia (CML) was assessed utilizing an observational, multicenter, prospective study design. All patients (N = 91) were adults with CML treated with generic imatinib, mainly 400 mg/day, who either received generic imatinib (n = 33) as first-line therapy “first-line patients “or switched from patented imatinib to generic imatinib “switched patients” (n = 58). The primary objective was to measure proportions (95% Confidence Interval (CI)) of optimal response for first-line and switched patients at 12 months of treatment with generic imatinib, as defined in the 2009 ELN guidelines (CCyR [no Ph+ metaphases], or MMR [a ratio of BCR-ABL1 to ABL1 ≤0.1% on the International Scale]) and assessed by complete blood counts, fluorescence in situ hybridization and real-time quantitative PCR. Results: A total of 84.8% (n = 28/33) of the first-line patients achieved complete hematologic response (CHR) within 3 months of starting generic imatinib therapy (100% after 6 months). Out of the 23 evaluable first-line patients, [(87%, 95% CI = 73% - 100%), (n = 20)] in the per-protocol population (60.6 %, 95% CI = 51% - 86%) of the 33 patients in the intention-to-treat (ITT) population) achieved an optimal response at 12 months. All 58 switched patients had CHR at enrollment. Out of the 55 evaluable switched patients, [(96.4%, 95% CI = 91%-100%), (n = 53)] in the PP population (91.4%, 95% CI = 83%-98%) of the 58 patients in the ITT population) gained or maintained an optimal response at 12 months after switching to generic imatinib therapy. Most (84.7%, n = 144 out of 170) adverse events (AEs) were mild. Frequencies of drug-related AEs were similar to patented imatinib. Conclusions: Efficacy and safety of generic imatinib among middle eastern population in routine clinical practice is comparable to that of patented imatinib, and to that of the global population. Clinical trial information: NCT02977312.

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