Continuous Low-Dose Ribociclib Active in Advanced Breast Cancer Causes Less Neutropenia

Excerpt:

“Continuous low-dose ribociclib shows preliminary activity, and has an acceptable safety profile as an alternative to intermittent ribociclib dosing when combined with fulvestrant in the treatment of postmenopausal women with hormone receptor (HR)-positive, HER2-negative advanced breast cancer.

“A phase Ib study, presented at the 2016 San Antonio Breast Cancer Symposium, demonstrated a confirmed partial response (PR) of 13.3% in the continuous ribociclib arm, compared with 23.1% in the intermittent ribociclib arm, but a lower rate of high-grade neutropenia in patients receiving continuous dosing of ribociclib.”

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New Research on Triple Negative Breast Cancer Emerges at ASCO 2016


The American Society of Clinical Oncology (ASCO) meeting of 2016 is behind us, but oncologists, patients, and journalists are still analyzing the most interesting presentations made there. Below, we describe some of the more prominent results in triple negative breast cancer (TNBC), both promising and disappointing.

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FDA Approves Granix Injection for Self-Administration in Patients with Severe Neutropenia

The gist: Doctors in the U.S. are now free to prescribe a treatment for severe neutropenia that patients can give to themselves at home. The treatment is called Granix. Being able to inject Granix at home could help patients reduce the number of visits to the doctor’s office. Neutropenia is a condition in which a patient has a lower-than-normal number of white blood cells in their bloodstream. It is a side effect of some cancer treatments.

“The FDA has approved a self-administered injection of the leukocyte growth factor tbo-filgrastim for patients with nonmyeloid malignancies, allowing more flexibility for physicians to prescribe the drug for in-office or at-home use, the drug’s manufacturer announced.

“Tbo-filgrastim (Granix, Teva Pharmaceuticals), which has been commercially available in the US since November, 2013, has been indicated to allow for the marketing of a new syringe that can be administered either by the patient or a caregiver without having to visit the physician’s office.

“ ‘In partnership with their physician, patients will be able to decide whether administering Granix via self-injection at home or by a healthcare professional is the right course for them,’ Lee S. Schwartzberg, MD, FACP, division chief of hematology oncology at the University of Tennessee Health Science Center, Knoxville, Tenn., said in a statement released by Teva. ‘Selecting a course of self-administration may allow patients to consolidate the number of required visits to their physician and allow additional access for patients who have challenges in visiting their providers.’ ”


Down Syndrome Ups Risk for Infection-Related Death in Pediatric ALL

“Researchers have identified Down syndrome as a major risk factor for infection-related mortality among pediatric patients with acute lymphoblastic leukemia (ALL) enrolled in the Medical Research Council UKALL 2003 trial.

“ ‘Our analysis demonstrated that a significant proportion of sepsis deaths occurred during induction and during periods of neutropenia,’ wrote researchers led by David O’ Connor, MD, of Imperial College London. ‘Thus increased awareness of the potential for septic complications is required when caring for patients during these high-risk periods.’ ”

“The currently reported rates of treatment-related mortality in trials of patients with ALL is between 2% and 4%, with the most common cause being infection. With ALL having such high survival rates in low-risk patients, reducing infection-related mortality is an important goal for improving outcomes with children with this disease, according to O’Connor and colleagues.”

 


Cyramza Yields a Modest Survival Benefit in Second-line NSCLC

“Cyramza™ (ramucirumab, IMC-1121B; Eli Lilly) is a human IgG1 monoclonal antibody directed against the extracellular domain of VEGFR-2. It was recently approved by the Food and Drug Administration (FDA) for advanced gastric cancer or gastroesophageal junction adenocarcinoma. On February 19, 2014, Lilly announced via press release that the REVEL trial was positive for both overall survival (OS) and progression-free survival (PFS) benefit. Results from the randomized, double-blind, placebo-controlled Phase III REVEL trial (NCT01168973) were reported at the 2014 annual meeting of the American Society of Clinical Oncology (ASCO). The trial evaluated docetaxel with or without Cyramza in squamous or non-squamous Stage IV non-small cell lung cancer (NSCLC) patients following disease progression after one prior platinum-based therapy.”

Editor’s note: A new targeted drug called Cyramza (aka ramucirumab) shows promise as a potential treatment for people with advanced non-small cell lung cancer (NSCLC). In a clinical trial, scientists tested the drug on volunteer patients with stage IV NSCLC. Compared to standard chemotherapy alone, patients who were treated with chemo plus Cyramza lived longer and had more time pass before their cancer worsened.

Update 6/9/14: According to Dr. Jack West of GRACE, the benefit of Cyramza is very minimal in the above-mentioned clinical trial, and is therefore not so promising.


Spectrum Pharmaceuticals Completes Enrollment in Phase 2 Trial of SPI-2012 – A Novel Long-Acting Granulocyte Colony Stimulating Factor (GCSF) to Treat Chemotherapy-induced Neutropenia

“Spectrum Pharmaceuticals (SPPI), a biotechnology company with fully integrated commercial and drug development operations and with a primary focus in Hematology and Oncology, today announced that the key phase 2 trial of its long-acting granulocyte stimulating factor analog developed using LAPSCOVERY technology (SPI-2012) has completed its Phase 2 study enrollment; this positions Spectrum for Phase 3 decision making before year end.”

Editor’s note: Neutropenia is a potentially life-threatening side effect of chemotherapy. This clinical trial is testing whether a treatment called LAPSCOVERY is effective against neutropenia.


Spectrum Pharmaceuticals Completes Enrollment in Phase 2 Trial of SPI-2012 – A Novel Long-Acting Granulocyte Colony Stimulating Factor (GCSF) to Treat Chemotherapy-induced Neutropenia

“Spectrum Pharmaceuticals (SPPI), a biotechnology company with fully integrated commercial and drug development operations and with a primary focus in Hematology and Oncology, today announced that the key phase 2 trial of its long-acting granulocyte stimulating factor analog developed using LAPSCOVERY technology (SPI-2012) has completed its Phase 2 study enrollment; this positions Spectrum for Phase 3 decision making before year end.”

Editor’s note: Neutropenia is a potentially life-threatening side effect of chemotherapy. This clinical trial is testing whether a treatment called LAPSCOVERY is effective against neutropenia.


Spectrum Pharmaceuticals Completes Enrollment in Phase 2 Trial of SPI-2012 – A Novel Long-Acting Granulocyte Colony Stimulating Factor (GCSF) to Treat Chemotherapy-induced Neutropenia

“Spectrum Pharmaceuticals (SPPI), a biotechnology company with fully integrated commercial and drug development operations and with a primary focus in Hematology and Oncology, today announced that the key phase 2 trial of its long-acting granulocyte stimulating factor analog developed using LAPSCOVERY technology (SPI-2012) has completed its Phase 2 study enrollment; this positions Spectrum for Phase 3 decision making before year end.”

Editor’s note: Neutropenia is a potentially life-threatening side effect of chemotherapy. This clinical trial is testing whether a treatment called LAPSCOVERY is effective against neutropenia.


Switching from Iressa to Tarceva Halts Drug-Induced Immune Suppression in Lung Cancer Patient

Neutropenia (a reduction in white blood cells) is a rare, but potentially serious side effect of the cancer drug gefitinib (Iressa). Iressa is used to treat non-small cell lung cancer (NSCLC) with mutations in the EGFR gene. A patient with EGFR-mutant advanced adenocarcinoma of the lung (a type of NSCLC) was treated with Iressa. Her tumor shrank, but she experienced severe neutropenia, leaving her at risk of dangerous infections. She was switched to erlotinib (Tarceva), another EGFR inhibitor, after which her neutropenia cleared up. The patient has since continued on Tarceva without neutropenia or cancer progression for over 9 months. This case suggests that Iressa-induced neutropenia can be safely treated by switching to Tarceva, although caution should be used in drawing conclusions from a single case study.