FDA approves Lynparza, companion diagnostic for BRCA-mutated ovarian cancer

FDA approves Lynparza, companion diagnostic for BRCA-mutated ovarian cancer
December 19, 2018: Healio – The FDA approved olaparib for the maintenance treatment of women with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Read more.

Evidence-Based Practice

Dear Colleagues and Friends of IGCS:

Data from important studies assist physicians, patients, and government regulators to make informed decisions. In oncology, we have established clinical research as a routine part of our day to day patient care. Investigators in cancer clinical trials aim to provide results which educate both patients and clinicians, particularly utilizing randomized, usually blinded, clinical trial formats to compare different groups of otherwise-similar patients.

Clinical advances in the area of therapeutics and gynecological malignancies recently published in The Lancet and Nature include the use of PARP INHIBITORS, both in BRCAgm and BRCAwt patients in the setting of recurrent ovarian cancer and, recently, in first line with the results of SOLO-1. Not since the introduction of cis-Platinum 30 years ago have we seen such exciting results in the management of women with ovarian malignancies. These trials have been well designed and conducted, have been published in highly regarded journals and need to be discussed when informing patients about their treatment options. Furthermore, they emphasize the importance of genetic testing in terms of prognosis and treatment options.

Recently, two major surgical studies have been published in The New England Journal of Medicine. The first is a well thought out and rigorous surgical trial published at the end of October entitled “Minimally Invasive versus Abdominal Radical Hysterectomy for Cervical Cancer” by P. Ramirez et al. This study is a prospective randomized Phase 3 Laparoscopic Approach to Cervical Cancer (LACC) trial. The other is “Survival after Minimally Invasive Radical Hysterectomy for Early-Stage Cervical Cancer” by Melamed A. et al, published in November which uses the National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) database. Both articles show a poorer outcome for patients treated with minimally invasive surgery in early stage cervical cancer. The authors of these studies are to be commended, as surgical trials are difficult and expensive to conduct. Despite all the potential bias, they present clear results about which our patients need advice when making decisions as to the surgical approach options in this clinical situation.

Incorporating clinical trial data into our clinical practice and treatment plans to improve the lives of women with gynecologic malignancies has always been part IGCS members’ approach to patient care. We believe that accurate patient counselling should be mandatory to individualize and tailor therapy based on accurate information about potential risks and benefits.

The use of clinical trials to bring about new approaches and novel therapies to patient care is fundamental to improving the lives of our patients. It is essential that we continue to advocate and support clinical trials in our specialty; our patients surely deserve no less. Where would our specialty be if we did not quickly adapt our clinical practice to reflect the outcomes of such trials?
I wish all of you a very happy holiday season and the best in 2019.


Roberto Angioli, MD
IGCS President

MD Anderson Launches Phase 2 HPV Vaccine Study

December 8, 2018: Precision Vaccinations – Phase 2 cancer study evaluating T cell-activating immunotherapy MEDI0457 with MedImmune’s durvalumab targeting several HPV-related cancers.

Inovio Pharmaceuticals announced the first patient dosing in a Phase 2 combination study targeting a broad array of cancers associated with the human papillomavirus (HPV), which is a group of more than 200 related viruses.

This open-label study is sponsored by Dr. Michael Frumovitz, MD, MPH, of the MD Anderson Cancer Center in Houston, Texas,  where the trial will be conducted as part of MD Anderson’s “Moon Shot” cancer initiative.

Read more.

Drug Duo Granted Breakthrough Status to Treat Endometrial Cancer

August 2, 2018: Cure – The FDA has granted a breakthrough therapy designation to the combination of Lenvima (lenvatinib) and Keytruda (pembrolizumab) for the treatment of patients with advanced and/or metastatic non–microsatellite instability high (MSI-H)/proficient mismatch repair endometrial carcinoma who have progressed after at least one prior systemic therapy. Read more.

Apatinib–etoposide shows promise in platinum-resistant ovarian cancer

Apatinib–etoposide shows promise in platinum-resistant ovarian cancer
August 15, 2018: Medwire News – Oral etoposide plus apatinib is associated with a good objective response rate and manageable toxicity in heavily pretreated Chinese women with platinum-resistant or refractory ovarian cancer, according to results of the phase II AEROC study. Read more.

FDA Approves Maintenance Rucaparib for Ovarian Cancer

The FDA has approved rucaparib (Rubraca) tablets for use as a maintenance treatment for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy, according to Clovis Oncology, the manufacturer of the PARP inhibitor.

Read more on this story from:
Clinical Oncology News