Updated data from two studies show that targeted therapy improves survival for women with difficult-to-treat cancer: two out of three are alive five years after the disease was discovered
Still considered today one of the most difficult cancers to cure among gynecological neoplasms, the ovarian cancer affects approximately 5,200 women every year only in Italy, with 3 thousand deaths a yearalso because the diagnosis is late in 80% of cases, given that la disease does not cause specific symptoms in the initial stages. For this reason, experts always use a lot of caution when talking about the news presented during scientific congresses. This time, however, even two of the leading specialists in the treatment of this pathology, let out a still cautious optimism: after years of small and continuous advances, we could really be at an “epochal turning point” that gives hope to be able to speak of healing also in those patients who come to discover the advanced stage neoplasm.
A true extension of survival
Nicoletta Colombodirector of the Oncological Gynecology Program of the European Institute of Oncology in Milan, associate professor at the Milan-Bicocca University, and Sunday Lorusso, associate professor of Obstetrics and Gynecology and head of Clinical Research Programming of the A. Gemelli University Hospital Foundation in Rome, are accustomed to very cautious tones, used to talking every day with women and family members who are facing a type of cancer that it often has a severe prognosis. In commenting on the scientific data of two large studies presented during the congress of the European Society of Oncology (European Society for Medical Oncology – Esmo), underway in Paris, they are however in agreement: for the first time there is not only talk of a small progress that earns months, albeit precious, but of a real prolongation of long-term survival, which lasts for years. «The 5-year survival of women diagnosed with ovarian cancer is still low, 43% – explains Colombo -. Today, however, there are targeted therapies. In the presence of specific genetic mutations, this neoplasm can be treated with targeted therapy, olaparib, progenitor of the class of PARP inhibitors, able to keep the disease under control and change clinical practice. And this is demonstrated by the positive results of the long-term follow-up of the phase III PAOLA-1 and SOLO-1 studies. “” Historically, the five-year survival rate of patients newly diagnosed with advanced ovarian cancer is 10-40 % – comments Saverio Cinieri, of the Italian Association of Medical Oncology (Aiom) -. Achieving long-term survival in these women is crucial, because the front-line setting offers the greatest potential to influence survival, which is why the updated data from the studies presented in Paris are very important, with two out of three patients alive “
The PAOLA-1 study
PAOLA-1 is a phase three study that evaluated the efficacy and safety of olaparib in addition to chemotherapy e bevacizumab, compared with bevacizumab alone, as first-line maintenance treatment in women with advanced, high-grade FIGO stage III-IV serous or endometrioid ovarian, fallopian or peritoneal cancer, who have shown complete or partial response to first-line treatment with platinum-containing chemotherapy and bevacizumab. “About 70% of women with advanced disease will relapse within two years – says Colombo -. Targeted treatment in the first-line maintenance setting is essential to help them live longer by delaying the progression of the disease. The five-year results of the PAOLA-1 study show that 65.5% of HRD positive (i.e. homologous recombination deficiency 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. Homologous recombination deficiencies (HRDs), which define a subgroup of ovarian cancer, include a wide range of genetic abnormalities, including BRCA and other mutations. As in the case of BRCA mutations, HRD interferes with normal cellular DNA repair mechanisms and confers sensitivity to PARP inhibitors, including olaparib.
The SOLO-1 study
SOLO-1 is a phase three, placebo-controlled, multicenter study evaluating the efficacy and safety of olaparib tablets as maintenance monotherapy versus placebo in patients newly diagnosed with BRCA-mutated advanced ovarian cancer following of platinum-based chemotherapy. The study involved 391 patients with a BRCA1 or BRCA2 mutation in complete or partial clinical response following platinum-based chemotherapy. Patients were randomized to receive olaparib or placebo for up to two years or to disease progression (at the oncologist’s discretion). “The long-term results of the SOLO-1 study, in advanced ovarian cancer with BRCA mutation, confirm that the benefit of olaparib monotherapy in the first-line maintenance setting extends well beyond the two-year maximum treatment limit while continuing to produce a clinically significant improvement in overall survival for more than seven years – underlines Lorusso -. 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 affirm that today, for some patients with advanced ovarian cancer, recovery is possible ».
September 12, 2022 (change September 12, 2022 | 14:01)
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