New Guidelines on Clinical Trial Design for Patients with Brain Metastases

Excerpt:

“Clinical trials of new anti-cancer therapies have often excluded patients whose disease has spread to the brain or central nervous system (CNS) or, if such patients were allowed on trial, trials have often failed to clearly capture information on the drug’s effect in the brain. Today new guidelines from an international, multidisciplinary group published in the journal Lancet Oncology describe how to most appropriately address cancer patients with CNS involvement within clinical trials of anti-cancer drugs.”

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Talazoparib Superior to Chemotherapy in BRCA-Associated Metastatic Breast Cancer

Excerpt:

“Approximately 5% of patients with sporadic breast cancer harbor mutations in BRCA1 or BRCA2; genes that are involved in the DNA repair process. Several phase I/II clinical studies have shown activity of single agent poly(ADP-ribose) polymerase (PARP) inhibitors in patients with metastatic breast cancer (MBC) and BRCA1/2 mutations. Recently in the randomized phase III OlympiAD trial, the PARP inhibitor olaparib improved progression-free survival (PFS) by 2.8 months over standard chemotherapy in patients with human epidermal growth factor 2 (HER2)–negative MBC and germline BRCA mutations.”

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FDA Approves Stereotactic Radiotherapy System for Breast Cancer

Excerpt:

“The FDA has approved a novel breast-specific stereotactic body radiotherapy (SBRT) device known as GammaPod as a treatment for patients with early breast cancer, based on findings from a 17-patient study.

“In the small clinical trial, GammaPod was effectively used to deliver a single ‘boost’ radiation dose of 8 Gy directly to the tumor, while only eliciting grade 1 adverse events (AEs). The system uses a vacuum-assisted breast cup guided by a CT simulator with 1 mm slice thickness to immobilize the breast, which ensures the accurate delivery of radiation to the tumor.”

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Cancer Clinical Trials Exclude Many Desperate Patients. Should That Change?

Excerpt:

“When 29-year-old Carly Bastiansen was diagnosed in January 2016 with advanced pancreatic cancer, doctors told her a clinical trial was her best shot at slowing the notoriously quick-killing and hard-to-treat disease. She found one that appeared promising and went through the screening process. But the trial would not accept her.

“ ‘Participating in a clinical trial is really my only chance at living longer,’ Bastiansen, a children’s librarian in Baltimore, said this fall as she was growing weaker. ‘To have had that option taken off the table was devastating.’ ”

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Talazoparib Tops Physician’s Choice for Advanced, BRCA-Positive Breast Cancer

Excerpt:

“The PARP inhibitor talazoparib significantly increased progression-free survival (PFS) over physician’s choice of therapy in a randomized phase III trial of patients with advanced breast cancer and a germline BRCA mutation.

“ ‘Talazoparib is a highly potent, dual-mechanism PARP inhibitor. It prevents the repair of DNA damage, and results in cell death,’ said Jennifer K. Litton, MD, of the University of Texas MD Anderson Cancer Center in Houston. A previous phase II study showed encouraging efficacy with the agent in patients with BRCA1/2 mutations, which led to the new EMBRACA trial. Litton presented results of the trial at the 2017 San Antonio Breast Cancer Symposium (SABCS), held December 5–9.”

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Abemaciclib/Pembrolizumab Combo Shows Early Promise for HR+/HER2- Breast Cancer

Excerpt:

“The combination of abemaciclib (Verzenio) and pembrolizumab (Keytruda) showed preliminary signs of activity without additive toxicity for patients with pretreated HR-positive, HER2-negative metastatic breast cancer, according to early results from a pilot trial presented in a poster at the 2017 San Antonio Breast Cancer Symposium (SABCS).

“At a 16-week analysis, the objective response rate (ORR) with the combination was 14.3%, which was less than the response rate seen with single-agent abemaciclib in the MONARCH-1 trial (19.7%). However, the trial investigators noted that the median time to response for abemaciclib has historically been 3.7 months, suggesting the efficacy is likely to improve with longer follow-up. At 16 weeks, the ORR in the MONARCH-1 trial was 6.8%.”

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Patients With Breast Cancer Harboring AR Biomarker Likely to Respond to Enzalutamide

Excerpt:

“In patients with hormone receptor (HR)-positive advanced breast cancer and no prior endocrine therapy who were positive for a gene signature-based biomarker indicating androgen receptor (AR)-signaling, the addition of enzalutamide (Xtandi) to exemestane was found to significantly improve progression-free survival (PFS) from 4 months to 16.5 months.

“Moreover, the phase II trial showed no effect of enzalutamide on PFS in the overall cohort of patients nor in the biomarker-positive population who received prior endocrine therapy, said Denise Yardley, MD, at the 2017 San Antonio Breast Cancer Symposium.”

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Continued Activity Reported for Pembrolizumab/Eribulin in TNBC

Excerpt:

“Updated results of the phase Ib/II ENHANCE1/KEYNOTE-150 study presented at the 2017 San Antonio Breast Cancer Symposium found that the combination of pembrolizumab (Keytruda) and eribulin (Halaven) was associated with a 26.4% objective response rate (ORR) for patients with metastatic triple-negative breast cancer (TNBC).

“In the open-label study, the ORR with the combination for untreated patients with metastatic TNBC (n = 65) was 29.2% (95% CI, 18.6%-41.8%). In a cohort of patients pretreated with 1 to 2 therapies (n = 41), the ORR was 22.0% (95% CI, 10.6%-37.6%). Across all treatment arms, there were 3 complete responses to the combination (2.8%).”

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Nab-Paclitaxel Shows Greatest Utility for TNBC

Excerpt:

“Treatment with nab-paclitaxel (Abraxane) showed promising improvements in overall survival (OS) and progression-free survival (PFS) compared with standard paclitaxel for patients with metastatic triple-negative breast cancer (TNBC), according to post-hoc findings from the CALGB 40502/NCCTG N063H trial presented at the 2017 San Antonio Breast Cancer Symposium (SABCS).

“For those with TNBC in the phase III trial (n = 201), the median OS with nab-paclitaxel was 21.0 months compared with 15.3 months with standard paclitaxel, representing a 26% reduction in the risk of death. Given the limitations of the post-hoc assessment, these findings were not powered for statistical significance, explained lead investigator Hope S. Rugo, MD. The hazard ratio for the comparison was 0.74 (95% CI, 0.51-1.07).”

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