Two out of 3 women with ovarian cancer are alive over the age of five. A breath of fresh air for those who carry the diagnosis of an advanced stage cancer on their shoulders. The good news comes from the Congress of the European Society of Medical Oncology (ESMO), taking place in Paris where positive results from the long-term follow-up of the Phase III PAOLA-1 (Abstract # LBA29) and SOLO-1 studies were presented (Abstract # 517O). Results that oncologists have defined as epochal and truly capable of representing a turning point for this type of tumor. Ovarian cancer is one of the most common gynecological cancers, with the worst prognosis and the highest mortality rate. More than two thirds of patients present with advanced disease at diagnosis and approximately 90-60% of these die within five years. This is why the data coming from Esmo is particularly important for patients.
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Few screening tools, but increasingly targeted therapies
Every year, in Italy, there are 5200 new diagnoses. Unfortunately, the 5-year survival is still low, equal to 43%, also because too many women, about 80%, discover the disease at an advanced stage. Furthermore, in this pathology, effective screening tools are lacking. Today, however, there are targeted therapies. In the presence of specific genetic mutations, this neoplasm can be treated with a targeted therapy, olaparib, progenitor of the class of PARP inhibitors, able to control the disease and change clinical practice, thanks to the excellent results highlighted in the scientific studies presented. to Esmo. “Historically, the five-year survival rate of newly diagnosed advanced ovarian cancer patients is 10-40%,” he says. Saverio Cinieri, President of AIOM (Italian Association of Medical Oncology). Achieving long-term survival in these women is crucial, because the frontline setting offers the greatest potential to affect survival. The updated data from the PAOLA-1 and SOLO-1 studies are very important, with two out of three patients alive ”.
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The new survival data
Positive long-term follow-up results from Phase III PAOLA-1 and SOLO-1 studies showed significant clinical improvements in overall survival and progression-free survival with olaparib in combination with bevacizumab, an antiangiogenic drug, for patients positive for homologous recombination deficiency (HRD), compared with bevacizumab, and with olaparib alone, for patients with BRCA mutations, compared to placebo. Both studies, which were conducted in biomarker-selected patients with newly diagnosed advanced ovarian cancer, in the frontline maintenance setting also demonstrated a safety profile consistent with previous findings.
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Risk of death reduced by 45%
The results of the SOLO-1 study were published in the Journal of Clinical Oncology. “The long-term results of the SOLO-1 study in advanced ovarian cancer with BRCA mutation – he points out Sunday Lorusso, Associate Professor of Obstetrics and Gynecology and Head of Clinical Research Planning at the A. Gemelli University Hospital Foundation in Rome – confirm that the benefit of olaparib monotherapy in the first-line maintenance setting extends well beyond the 2-year maximum treatment limit by continuing to produce a clinically significant improvement in overall survival for more than seven years. Olaparib reduced the risk of death by 45% and, at seven years, 67% of the women were alive compared to 47% with placebo. In addition, the mean time to first subsequent therapy was 64 months with olaparib compared with 15.1 months with placebo. These data allow us to state that today, for some patients with advanced ovarian cancer, recovery is possible ”.
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Genetic mutations in ovarian cancer
One in five women with advanced ovarian cancer has a BRCA mutation, and about half have HRD-positive cancers (which include cancers with a BRCA mutation). “The homologous recombination defect (HRD) – continues Cinieri – represents an ‘error’ in the repair mechanism of the DNA double helix, present in about 50% of cases. The results of the two studies further underline the importance, at the time of diagnosis, of the HRD test, which also allows the detection of BRCA mutations, for all patients with advanced ovarian cancer. In fact, homologous recombination deficiencies define a subgroup of ovarian cancer and include a wide range of genetic abnormalities, including BRCA mutations. The HRD test must be the first step in a precision medicine approach to define the best therapy. We hope that it will be reimbursed as soon as possible in our country, because it is essential for the selection of patients who can benefit from personalized first-line treatment with targeted therapy ”.
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The Paola-1 study
About 70% of women with advanced disease relapse within two years. “Targeted treatment in the first-line maintenance setting – he explains Nicoletta ColomboDirector of the Oncological Gynecology Program of the European Institute of Oncology in Milan and Associate Professor at the Milan-Bicocca University – is essential to help them live longer, delaying the progression of the disease. The five-year results of the PAOLA-1 study show that 65.5% of HRD positive patients treated with olaparib in combination with bevacizumab are alive at five years compared to 48.4% with bevacizumab alone. The combination reduced the risk of death by 38%, further confirming the clinically significant long-term survival benefit. Furthermore, the addition of olaparib resulted in progression-free survival to a median of nearly 4 years, ie 46.8 months compared with 17.6 with bevacizumab alone.