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30 Nov 2018
New drug applications approved by US FDA as of 16 - 30 November 2018 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.
Roshini Claire Anthony, 16 Dec 2016

Five years of extended therapy with the aromatase inhibitor (AI) letrozole did not improve survival in postmenopausal breast cancer patients, according to findings of the NRG Oncology/NSABP B-42 trial presented at the San Antonio Breast Cancer Symposium (SABCS 2016) held in Texas, US. 

Jackey Suen, 21 Dec 2016

Adding everolimus to fulvestrant in second-line treatment of hormone receptor (HR)-positive, HER2-negative advanced breast cancer improves progression-free survival (PFS) by 40 percent, the phase II PrECOG 0102 study has shown. [SABCS 2016, abstract S1-02]

Week-on week-off gem/nab-P on par with standard regimen for metastatic pancreatic cancer

Stephen Padilla
27 Nov 2017

A week-on week-off (WOWO) gemcitabine/nab-paclitaxel (gem/nab-P) regimen appears to be as effective but potentially less toxic than standard gem/nab-P for advanced pancreatic cancer, according to a study presented at the European Society for Medical Oncology (ESMO) Asia 2017 Congress.

“The MPACT study established the role of gem/nab-P as first-line treatment for advanced pancreatic cancer,” researchers said. “Treatment was administered (weekly), but most trial patients required dose reductions and/or delay.”

A retrospective review of patients with advanced pancreatic cancer was conducted to examine the characteristics and outcomes of those treated with weekly gem/nab-P vs those switched from initial weekly to WOWO gem/nab-P. Patient demographics, disease characteristics, treatment, toxicity and survival outcomes were recorded.

A total of 35 patients were included (mean age 65 years; 60 percent men). There were 20 patients (57 percent) maintained on standard gem/nab-P, of which 30 percent required a dose reduction and 70 percent a dose delay or omission. [ESMO Asia 2017, abstract 229P]

The other 15 patients (43 percent) switched to WOWO due to the following reasons: haematological toxicity, fatigue, poor performance status and peripheral neuropathy.

The WOWO group received a median number of six cycles and four for the standard group. Cessation of chemotherapy due to toxicity did not differ between the two groups, but more patients in the WOWO group discontinued treatment due to progressive disease (47 vs 40 percent; p=NS).

Progression-free survival was similar in both groups (6.7 vs 7.2 months in the WOWO and standard groups, respectively; hazard ratio [HR], 0.73; 95 percent CI, 0.35 to 1.54; p=0.40). There was also no significant difference in the overall survival between the two groups (11.9 vs 11.3 months; HR, 0.70; 0.30 to 1.66; p=0.78).

“Although limited by its retrospective nature and small sample size, this audit suggests WOWO gem/nab-P may be as effective yet potentially less toxic than weekly gem/nab-P for advanced pancreatic cancer,” researchers said.

In a subanalysis of the MPACT study, researchers found that prolonged first-line treatment exposure to gem/nab-P and the ability to receive subsequent therapies were associated with improved survival among patients with metastatic pancreatic cancer (MPC). Data from this study also stressed the significance of managing adverse events and suggested that patients should be treated until progressive disease when possible. [BMC Cancer 2016;16:817]

George Kim, a medical oncologist from the University of Florida Health Oncology, has said in his systematic review that “gem/nab-P is an effective regimen for the first-line treatment of MPC for a wide range of patients. Regimens using nab-P/Gem as a backbone on which to combine additional agents are being studied actively, particularly in the advanced disease setting.” [Cancer Manag Res 2017;9:85–96]

Gemcitabine is a cytotoxic agent while nab-paclitaxel is an albumin-bound formulation of paclitaxel that appears to reduce levels of cytidine deaminase, which is the primary gemcitabine catabolic enzyme. [J Gastrointest Oncol 2013;4:E16-8]

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Most Read Articles
29 Nov 2019
Metformin Extended Release 500 mg,750 mg, and 1000 mg
30 Nov 2018
New drug applications approved by US FDA as of 16 - 30 November 2018 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.
Roshini Claire Anthony, 16 Dec 2016

Five years of extended therapy with the aromatase inhibitor (AI) letrozole did not improve survival in postmenopausal breast cancer patients, according to findings of the NRG Oncology/NSABP B-42 trial presented at the San Antonio Breast Cancer Symposium (SABCS 2016) held in Texas, US. 

Jackey Suen, 21 Dec 2016

Adding everolimus to fulvestrant in second-line treatment of hormone receptor (HR)-positive, HER2-negative advanced breast cancer improves progression-free survival (PFS) by 40 percent, the phase II PrECOG 0102 study has shown. [SABCS 2016, abstract S1-02]