MUNICH—A “salutary lesson” was reported by researchers investigating therapy for oropharyngeal cancer at the 2018 annual congress of the European Society for Medical Oncology (ESMO). It came from results of the De-ESCALaTE HPVstudy that found patients with low-risk head and neck cancer who tested positive for human papilloma virus (HPV+) did better if they had been treated with standard platinum-based chemotherapy (added their radiotherapy) rather than the epidermal growth factor receptor (EGFR) inhibitor cetuximab.
Phase three trials needed
“One of the big lessons is that you really need phase three trials—even when treatments are already approved—as in [the] case [of] head and neck cancer,” said Hisham Mehanna PhD BMed Sci FRCS, Chair of Head and Neck Surgery at the Institute for Head and Neck Studies Education in the University of Birmingham, UK. “You need phase three trials to compare new treatments to standards of care to really be able to take [them] into the clinic,” he told the Audio Journal of Oncology. “Clinical practice should not be changed without these phase three trials.”
Detriment from cetuximab
TheDe-ESCALaTE HPV study—reported at ESMO by Mehanna and his colleagues—found there had been “significant detriment from the use of cetuximab instead of cisplatin in terms of tumor control and no benefit in terms of reduced toxicity. They concluded that: “Cisplatin and radiotherapy remained the standard of care in this setting.”Hisham Mehanna discusses head and neck cancer de-escalation
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MUNICH—A leading European oncologist acknowledged the impressive life-extending potential of new drug combinations for metastatic renal cell carcinoma discussed at the 2018 annual congress of the European Society for Medical Oncology (ESMO). Progress was reported with purely immunological approaches—using two different programmed death ligand 1 (PD-L1) targeted immunotherapies together—and also with therapies combining immunotherapy with tyrosine kinase inhibitors (TKIs) of vascular endothelial growth factor (VEGF).
Although such combinations had improved progression free survival (PFS) and even promised prolongation of overall survival (OS) the lack of comparisons between them left clinicians with little guidance—other than toxicity profiles—upon which to individualize treatment for their patients.
“Unfortunately we don’t have good biomarkers that would help us selecting patients who would benefit either from immunotherapy alone, VEGF targeting agents alone, or the combination. So we have to look at the safety profiles of the combinations that we have right now—either the combinations with immunotherapies (alone) or the combination of a VEGF targeting agent and an anti PD-L1 drug—and see what would be the best for the patient that you have in front of you,” the Audio Journal of Oncology heard from John B.A.G. Haanen MD PhD, Chief Scientific Officer Immunotherapy and Consultant Medical Oncologist in the Division of Medical Oncology and Immunotherapy at the Netherlands Cancer Institute in Amsterdam.
John Haanen Audio Journal of Oncology
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MUNICH— A doubling of progression free survival (PFS) and objective response rate (ORR) was observed in patients who had their previously untreated advanced renal cell cancer (RCC) treated with a combination of the vascular endothelial growth factor (VEGF) inhibitor axitinib plus the anti-programmed death one ligand (PD-L1) avelumab in comparison with those receiving standard sunitinib anti-VEGF therapy in the randomized phase threeJAVELIN Renal 101 clinical trial. Findings were reported at the 2018 annual congress of the European Society for Medical Oncology (ESMO). http://126.96.36.199/slidecenter/esmo2018/attendee/confcal/session/calendar?q=LBA6_PR
“The progression free survival was so robust, the objective response rate was robust [and] the safety profile was favorable that [this] warrants this combination as a new standard of care in patients with advanced kidney cancer,” lead investigator of the study Robert J Motzer MD PhD, a medical oncologist at Memorial Sloan-Kettering Cancer Center in New York told the Audio Journal of Oncology.Robert Motzer ESMO AJO
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MUNICH— Anaplastic lymphoma kinase (ALK) inhibitors are as effective in “real world” clinical use for treating patients with non-small cell lung cancer (NSCLC) who test positive for ALK gene rearrangements as they are in clinical studies—even though randomized trials “cherry pick” patients to get statistically valid results. This is the conclusion of a retrospective analysis of data reported at the 2018 annual congress of the European Society for Medical Oncology (ESMO). http://188.8.131.52/slidecenter/esmo2018/attendee/confcal/session/calendar?q=jahanzeb
Progression free survival (PFS) was prolonged to a median of 7.4 months in the overall group of patients treated with ALK-targeted agents. “We were delighted to find out that these patients do as well as patients on clinical trials,” said author Mohammad Jahanzeb MD, Professor of Clinical Medicine, Hematology-Oncology and Medical Director of the University of Miami Sylvester Comprehensive Cancer Center in Deerfield Florida talking to the Audio Journal of Oncology. “Median progression free survival was in the same ball-park as we see in clinical trials.”
Jahanzeb said that prospective clinical trials excluded many real world patients who had comorbid conditions and factors such as brain metastases—which were often encountered among typical real-world patients. “So we thought it was really important to go to a database repository and do a “deep-dive” on the subset of patients positive for ALK,” he said, noting that half of these patients typically had brain metastases.Mohammad Jahanzeb AJ0
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MUNICH—The role of poly ADP ribose polymerase (PARP) inhibitors for treating newly diagnosed advanced ovarian cancer was under review at the 2018 annual congress of the European Society for Medical Oncology (ESMO) in the light of findings from the SOLO1 randomized phase three trial in which there was more than a doubling of the numbers of patients surviving three years without disease recurrence in patients with BRCA gene mutations who were treated with olaparib after initial chemotherapy compared with similar patients receiving a placebo.
Commenting on the findings Jonathan Ledermann MD FRCP Professor of Medical Oncology, Director of the UCL Cancer Trials Centre and Clinical Director at the UCL Cancer Institute in University College London said the study had been a first. “We know that olaparib and other PARP inhibitors are very successful in delaying disease progression in patients with recurrent disease. But this trial tested maintenance olaparib in the front-line setting after surgery and chemotherapy—and that was unique,” he tells the Audio Journal of Oncology.Jonathan Ledermann AJO
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BRCA1/2 Ovarian Cancer—Three Years Disease Free with First-Line Olaparib
MUNICH—An “unprecedented improvement” in progression free survival (PFS) was observed in the randomized controlled double-blind phase three SOLO1 study of women with newly diagnosed ovarian cancer who had BRCA1/2 mutations and were treated with the poly ADP ribose polymerase (PARP) inhibitor olaparib after their standard initial platinum-based induction chemotherapy.
A three years extension of median PFS and the expectation of a robust superiority in overall survival (OS)—compared with the patients who had placebo therapy following their platinum induction chemotherapy—were reported at the 2018 annual congress of the European Society for Medical Oncology, ESMO.
Patients will demand
“It’s practice changing. Patients are going to be demanding this when these results are made public. I think rightly so,” said first author Kathleen Moore MD, Associate Director for Clinical Research at the Stephenson Cancer Center, University of Oklahoma in Oklahoma City. “We’re going to need to get the drug approved in this line—it’s not approved in front-line [therapy] in any part of the world,” she told the Audio Journal of Oncology.Kathleen Moore OLAPARIB FIRST LINE IN OVAIAN CANCER
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MUNICH— Immunotherapy with the anti programmed death ligand 1 (PD-L1) checkpoint inhibitor atezolizumab in combination with nab-paclitaxel chemotherapy prolonged progression-free survival (PFS) among patients with metastatic triple-negative breast cancer in the randomized phase three IMpassion130 trial reported at the 2018 annual congress of the European Society for Medical Oncology, ESMO.
The experimental treatment also prolonged overall survival (OS) in patients who tested positive for PD-L1—the molecular target of atezolizumab.
“For me this is practice-changing. This is a massive step. This is the first time—a clear improvement in overall survival, not just a marginal improvement. We see a transformative benefit of nearly ten months based on survival in the control group of only 15 months. So it’s more than a 50 per cent improvement in overall survival which is a very meaningful result for patients with this difficult-to-treat sub-type of breast cancer.”
So said first author of the IMpassion130 trial Peter Schmid MD PhD, Chair of Oncology at Barts Cancer Institute and Queen Mary University of London and Director of St. Bartholomew’s Breast Cancer Centre in London UK in conversation with the Audio Journal of Oncology.Peter Schmid AJO Atezolizumab Extends Lif e in Triple Negative Breast Cancer
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MUNICH—A combination of the phosphoinositide 3-kinase (PI3K) inhibitor alpelisib plus fulvestrant significantly extended progression free survival (PFS) compared to placebo plus fulvestrant in patients with hormone receptor positive (HR+) human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer in the randomized phase three SOLAR-1 trial reported at the 2018 annual congress of the European Society for Medical Oncology, ESMO.
“This study opens the door for precision medicine in metastatic breast cancer,” said lead investigator Fabrice André MD PhD, Associate Professor in the Department of Medical Oncology at Institut Gustave Roussy in Villejuif, France. This had been the first study to show statistically significant clinically meaningful PFS improvement with an alpha isoform-specific PI3K inhibitor in patients with HR+ HER2- advanced breast cancer and mutated oncogene PIK3CA, he said, and the drug had a “manageable toxicity profile”.
“[This] alpha selective PI3 kinas inhibitor improves progression free survival in a clinically meaningful way in patients who present [with] mutational PI3 kinase,” André tells the Audio Journal of Oncology. He noted that SOLAR-1 had been the first study to show a benefit from a targeted therapy driven by genomics.Fabrice André ESMO 2018 AJO Genomic Breast Cancer Targeting
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MUNICH—Patients with hormone receptor-positive (HR+) human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer who were treated with a combination of the cyclin dependent kinase (CDK) 4/6 inhibitor palbociclib in combination with fulvestrantlived longer than those receiving a placebo with fulvestrant in the prospective, randomized, double-blind, phase three PALOMA-3 study from which overall survival (OS) data were reported at the 2018 annual congress of the European Society for Medical Oncology, ESMO.
“This combination should be the standard of care for patients progressing on endocrine therapy,” said PALOMA-3 study senior investigator Massimo Cristofanilli MD FACP, Professor of Medicine at the Robert H. Lurie Comprehensive Cancer Center, Feinberg School of Medicine, Northwestern University in Chicago IL. He tells the Audio Journal of Oncology: “There’s no doubt there is a clinical and meaningful strong benefit—not only in delaying the disease but also [in] survival. This should replace the use of chemotherapy,” he said.
The trial found that patients taking the CDK4/6 inhibitor with fulvestrant lived a median of 6.9 months longer than those in the control group treated with placebo and fulvestrant.Massimo Cristofanilli AJO PRODUCTION MASTER
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MUNICH—More than four years median overall survival was reported in patients treated with an inhibitor of anaplastic lymphoma kinase (ALK) for their ALK gene rearranged non-small cell lung cancer (NSCLC) in a single-arm phase two study reported at the 2018 annual congress of the European Society for Medical Oncology, ESMO.
“The information presented here showed that for patients included in the ASCEND 3 trial—ALK positive patients previously treated with chemotherapy—who received ceritinib as their first ALK inhibitor there [was] an overall survival of 51 months. This is really encouraging,” said lead author Enriqueta Felip MD PhD, medical oncologist and Chair of the Thoracic Malignancies Group at Vall d’Hebron University Hospital in Barcelona, Spain, talking to the Audio Journal of Oncology.181019 Enriqueta Felip AJO PRODUCTION MASTER
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