Overall survival data from LUX-Lung 7 head-to-head trial of Afatinib versus Gefitinib

MedicalResearch.com Interview with:

Shirish Gadgeel, MD Leader of the Thoracic Oncology Multidisciplinary team Professor at Karmanos Cancer Institute Detroit

Dr. Shirish Gadgeel

Shirish Gadgeel, MD
Leader of the Thoracic Oncology Multidisciplinary team
Professor at Karmanos Cancer Institute
Detroit

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: LUX-Lung 7 is the first global, head-to-head trial comparing second- and first-generation EGFR-directed therapies (afatinib and gefitinib respectively) for patients with EGFR mutation-positiveNon-Small Cell Lung Cancer NSCLC who received no prior treatment. The Phase IIb trial included 319 patients with advanced stage NSCLC harboring common EGFR mutations (del19 or L858R). The trial’s co-primary endpoints were progression-free survival (PFS) by independent review, time to treatment failure and overall survival (OS); and the secondary endpoints included ORR, disease control rate, tumor shrinkage, patient-reported outcomes and safety.

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Abraxane Demonstrates Benefit Over Paclitaxel in Metastatic Breast Cancer

MedicalResearch.com Interview with:

Corey Pelletier PhD Director, Health Economics & Outcomes Research at Celgene Celgene Corporation Summit, NJ

Dr. Corey Pelletier

Corey Pelletier PhD
Director, Health Economics & Outcomes Research
Celgene Corporation
Summit, NJ

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: In a phase III clinical trial, ABRAXANE demonstrated significant improvement in ORR vs paclitaxel in patients with metastatic breast cancer. Celgene initiated this study because limited data exist on the comparative effectiveness of ABRAXANE vs paclitaxel for patients with metastatic breast cancer, including HR+/HER2- and triple negative (TN) metastatic breast cancer (MBC), in a real-world setting. This study used a U.S. based electronic medical record (EMR) dataset to evaluate the real-world comparative effectiveness of second-line ABRAXANE vs paclitaxel in patients with MBC and included patients with HR+/HER2- or TN MBC. This study also assessed adverse events and use of supportive care in this patient population.

The median time to treatment discontinuation (TTD) for ABRAXANE vs paclitaxel was 4.50 vs 2.83 months (adjusted P<0.0001*) in all patients. Patients with HR+/HER2- or TN MBC had similar TTD. The median time to next treatment (TTNT) in all patients was 5.9 vs 4.2 months (adjusted P=0.2140*) for ABRAXANE vs paclitaxel, respectively. Patients receiving ABRAXANE had less fatigue, neuropathy, and anemia compared to patients receiving paclitaxel. Patients treated with ABRAXANE also used less antiemetics, and had fewer treatments for hydration or allergic reaction compared to those treated with paclitaxel. Patients treated with paclitaxel used less GCSF and had fewer treatments for bone loss compared to those treated with ABRAXANE.

*TTD and TTNT were adjusted for age, number of metastases, targeted agent use, adjunctive chemotherapy, HER2 status, TN status, and CCI score without age.

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Combination Everolimus/Exemestane For ER+|HER2- Advanced Breast Cancer

MedicalResearch.com Interview with:

Melanie Royce, MD, PhD Professor of Medicine University of New Mexico School of Medicine Director of the Breast Multidisciplinary Clinic and Program UNM Cancer Center. Albuquerque, NM

Dr. Melanie Royce

Melanie Royce, MD, PhD
Professor of Medicine
University of New Mexico School of Medicine
Director of the Breast Multidisciplinary Clinic and Program
UNM Cancer Center.
Albuquerque, NM

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: BOLERO-4 is an open label, single-arm, Phase II study that evaluates the combination of everolimus plus letrozole as a first-line treatment for hormone receptor (HR)-positive/HER2-negative advanced breast cancer patients, as well as the use of everolimus plus exemestane beyond initial progression.

Results of the Phase II BOLERO-4 clinical trial, presented as an oral presentation at the 2016 European Society for Medical Oncology (ESMO) annual meeting, show preliminary evidence that everolimus in combination with letrozole is effective in treating women with HR-positive/HER2-negative advanced breast cancer in the first-line setting. With follow up of 17.5 months, the median progression-free survival (PFS) is not yet reached. At six months, 83.6% (95% CI: 77.3-88.2%) of women taking everolimus plus letrozole in the first-line setting were without disease progression, and 71.4% (95% CI: 64.0%-77.5%) did not have disease progression at twelve months.

Safety findings from BOLERO-4 are consistent with previous studies of everolimus in advanced breast cancer, with the most common adverse events being stomatitis (67.8%), weight loss (42.6%) and diarrhea (36.1%). These adverse events were mostly grade 1 or 2 in severity1.

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PD-1 Blockers Offer Hope To Some Patients With Metastatic Urothelial Cancer

MedicalResearch.com Interview with:

Arjun Balar, M.D. Assistant Professor of Medicine Director - Genitourinary Medical Oncology Program NYU Perlmutter Cancer Center New York, NY 10016

Dr. Arjun Balar

Arjun Balar, M.D.
Assistant Professor of Medicine
Director – Genitourinary Medical Oncology Program
NYU Perlmutter Cancer Center
New York, NY 10016

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Standard treatment for advanced urothelial cancer includes cisplatin-based chemotherapy which has been shown to improve survival. But more than half of patients are not expected tolerate it well and alternative treatment is inferior to cisplatin. The average survival for these patients is in the range of 9-10 months with carboplatin-based treatment, which is the most commonly used alternative to cisplatin. Pembrolizumab is a PD-1 blocking antibody that reactivates the body’s cancer-fighting T-cells (part of the immune system) to fight urothelial cancer.

The trial overall enrolled 374 patients who had not yet received any treatment for advanced urothelial cancer, but were considered ineligible for cisplatin chemotherapy.

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Niraparib Increased Progression Free Survival in 2/3 Ovarian Cancer Patients

MedicalResearch.com Interview with:

Mansoor Raza Mirza, MD Medical Director: Nordic Society of Gynecologic Oncology (NSGO) Board of Directors: Gynecologic Cancer Inter-Group (GCIG) Faculty: European Society of Medical Oncology (ESMO) Faculty: International Gynecologic Cancer Society (IGCS) Chief Oncologist, Rigshospitalet Copenhagen University Hospital Copenhagen, Denmark

Dr. Mansoor Raza Mirza

Dr. Mansoor Raza Mirza, MD
Medical Director: Nordic Society of Gynecologic Oncology
Board of Directors: Gynecologic Cancer Inter-Group (GCIG)
Faculty: European Society of Medical Oncology (ESMO)
Faculty: International Gynecologic Cancer Society (IGCS)
Chief Oncologist, Rigshospitalet
Copenhagen University Hospital
Copenhagen, Denmark

MedicalResearch.com: What is the background for this study?

Response: Recurrent ovarian cancer is an area of significant unmet medical need, and there have been few therapeutic advances for these patients in the past few decades.

Niraparib was studied to provide patients with recurrent ovarian cancer an option other than “watchful waiting,” potentially redefining the standard of care for the disease. The ENGOT-OV16/NOVA trial was a Phase 3 double-blind, randomized, placebo-controlled international study of maintenance treatment with niraparib compared with placebo. Niraparib successfully achieved the primary endpoint of prolonging progression-free survival versus placebo in all three prospectively defined primary efficacy populations:
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Second-line Metastatic Urothelial Carcinoma Treatment and Survival in Real-World Patients

MedicalResearch.com Interview with:

Dr. Mathew Galsky MD Associate Professor, Medicine, Hematology and Medical Oncology Assistant Professor, Urology Director, Genitourinary Medical Oncology The Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai

Dr. Mathew Galesky

Dr. Mathew Galsky MD
Associate Professor, Medicine, Hematology and Medical Oncology
Assistant Professor, Urology
Director, Genitourinary Medical Oncology
The Tisch Cancer Institute
Icahn School of Medicine at Mount Sinai

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Since the development of combination cisplatin-based chemotherapy for the treatment of metastatic bladder (urothelial) cancer several decades ago, there have been few advances in the treatment of this disease. Further, until recently, there had been no global standard treatment options for patients with metastatic urothelial cancer progressing despite platinum-based chemotherapy. Several lines of evidence suggest that urothelial cancer may be sensitive to immunotherapeutic treatment strategies. Recently, in a phase I/II study published by Sharma and colleagues in Lancet Oncology, the anti-PD-1 antibody Nivolumab demonstrated a durable objective response rate of 24% in patients with metastatic urothelial cancer progressing despite platinum-based chemotherapy. To confirm to antitumor effects of Nivolumab in this patient population, we conducted a large global multicenter single-arm phase II study

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One Stop Cancer Screening May Increase Participation Rates

MedicalResearch.com Interview with:

Dr. Amanda Bobridge University of South Australia Adelaide

Dr. Amanda Bobridge

Dr. Amanda Bobridge
University of South Australia
Adelaide

MedicalResearch.com: What is the background for this study?

Response: Despite cancer screening being demonstrated to reduce cancer morbidity and mortality, current participation in established screening programs is variable. In Australia, the participation rates range from 37% for bowel cancer (FOBT) screening to 57% for cervical cancer screening.

This study aimed to determine the barriers to and enablers for cancer screening and whether the target population for screening would support the concept of combined cancer screening (all screening offered at the same time at the same location).

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Anti-Tumor Activity of PM01183 (lurbinectedin) in BRCA1/ 2-associated Metastatic Breast Cancer Patients

MedicalResearch.com Interview with:

Judith Balmana MD Medical Oncology Hospital Vall d’Hebron and Vall d’Hebron Institute of Oncology Barcelona, Spain

Dr. Judith Balmaña

Judith Balmaña MD
Medical Oncology
Hospital Vall d’Hebron and
Vall d’Hebron Institute of Oncology
Barcelona, Spain

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Tumors  with brca1 or brca2 mutations share homologous recombination repair deficiency, which confers sensitivity to different types of dna damaging agents. An understanding of the role of brca1 and brca2 in the repair of double-stranded dna damage opened a window of opportunity for treating brca mutation–associated cancers with targeted therapies.

Lurbinectedin is a trabectedin analog that specifically binds to cg-rich motifs with a selective mechanism of action: in living cells, lurbinectedin inhibits active transcription by degradation of elongating rna polymerase ii. This process occurs specifically on activated genes and is associated with the formation of double strand dna breaks and the collapse of replication forks. In addition, lurbinectedin exerts some antitumoral effect in the microenvironment by inhibiting the transcription of selected cytokines by tumor-associated macrophages, abrogating their protumoral properties. Observations that lurbinectedin was active against homologous-recombination-deficient cell lines led us to test it in patients with metastatic breast cancer having deleterious germline brca mutations.

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Physicians Should Be Critical of Adverse Event Reporting in Clinical Trials

MedicalResearch.com Interview with:

Paolo Bossi MD Medical Oncologist Head and Neck Cancer Department  IRCCS Istituto Nazionale dei Tumori Foundation Milan, Italy

Dr. Paolo Bossi

Paolo Bossi MD
Medical Oncologist
Head and Neck Cancer Department
IRCCS Istituto Nazionale dei Tumori Foundation
Milan, Italy

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Precise, clear and unbiased reporting of adverse events (AE) is essential to ensure safety of the new drugs.

It is crucial also in engaging patients and physicians in a shared decision making: before starting a new treatment I need to discuss with my pt what are the expected benefits and what the toxicities of a new drugs.
However, in parallel to the discovery and development of new drugs, little attention has been paid to modernization of the way of collecting toxicities.

This line of reasoning is particularly true for new or “relatively new” drugs, such as immunotherapy (IT) and targeted agents (TT).

So, we analysed all the trials that lead to the approval of TT or IT from 2000 – 2015 retrieved by FDA database.

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Many Europeans Lack Access To New Medications For Metastatic Melanoma

MedicalResearch.com Interview with:

Prof. dr Lidija Kandolf Sekulovi

Prof. Kandolf

Prof. dr Lidija Kandolf Sekulovic MD, PhD
EADO project access to innovative medicines coordinator
Interdisciplinary Melanoma team, Department of Dermatology
Medical Faculty, Military Medical Academy
Belgrade, Serbia

MedicalResearch.com: What made you set out to organize this survey?

Response: Before 2011 there were no effective treatment options for metastatic melanoma patients, but that have tremendously changed in the last 5 years. Now we have innovative medicines which are able to prolong overall survival of these patients to more than 18 months, and in some patients, durable responses lasting for up to 10 years are not infrequently reported. However, the access to these medicines is restricted, and patients and physicians are facing more and more difficulties to obtain them. This is especially the case for countries of Eastern and South-Eastern Europe, where majority of patients are still treated with palliative chemotherapy that does not prolong overall survival. We wanted to explore this issue more deeply, to map the access to innovative medicines between 1st May 2015 to 1st May 2016, and particularly the access to first-line treatment recommended by ESMO and EDF/EORTC/EADO guidelines that are based on scientific evidence and which are published in 2015 and 2016.

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