China News Service, Beijing, March 25 (Reporter Li Chun) Recently, at the annual meeting of the annual international authoritative gynecological oncology academic conference - the American Society of Gynecological Oncology (SGO), the director of the Department of Gynecological Oncology, Cancer Hospital of the Chinese Academy of Medical Sciences The detailed data of PRIME, a phase III clinical study of ovarian cancer PARP inhibitor nirapa led by Professor Wu Lingying, was used in the first-line maintenance treatment of ovarian cancer in China.
This study confirms that in newly diagnosed Chinese patients with advanced ovarian cancer, regardless of patient biomarker status, niraparib as maintenance therapy resulted in statistically and clinically meaningful progression-free survival following response to platinum-based chemotherapy. Both were significantly improved, and the safety was tolerable.
As the principal investigator, Lingying Wu said that the data results of the PRIME study will have a significant impact on the clinical practice of first-line treatment of ovarian cancer in China and other regions, and its individualized starting dose regimen has demonstrated improved efficacy and safety.
"Furthermore, the PRIME study is the only study conducted in China to demonstrate that PARP inhibitor single-agent first-line maintenance therapy is effective in newly diagnosed ovarian cancer patients in China, regardless of biomarker status and postoperative residual disease status. Clinical studies that significantly improve PFS. This undoubtedly adds strength to the maintenance treatment of the whole population of first-line ovarian cancer patients in China."
China's advanced ovarian cancer first-line maintenance treatment data released
Ovarian cancer maintenance therapy is divided into first-line maintenance therapy after initial therapy, and second-line or above maintenance therapy after platinum-sensitive recurrence therapy.
Wu Lingying pointed out that for newly diagnosed ovarian cancer patients, initial treatment is very important, and delaying recurrence as much as possible after first-line treatment is beneficial to patient survival.
Today, the first-line maintenance therapy of PARP inhibitors represented by niraparib has become the standard treatment for ovarian cancer patients after complete or partial remission from first-line therapy, which can help better delay recurrence, prolong progression-free survival, and reduce resistance Medicine.
As the largest phase III clinical study of PARP inhibitors in the first-line maintenance treatment of advanced ovarian cancer in China, the PRIME study represents the highest level of evidence-based medical evidence for PARP inhibitors in the first-line maintenance treatment of newly diagnosed advanced ovarian cancer in China.
The PRIME study, led by Professor Wu Lingying and participated by 29 research centers across the country, lasted 3 years and evaluated 384 patients with advanced ovarian cancer.
After achieving a complete or partial response to first-line platinum-based chemotherapy, these patients were randomly assigned in a 2:1 ratio to niraparib or placebo to receive maintenance therapy to evaluate the effectiveness of niraparib as maintenance therapy.
Wu Lingying said that the results of the study showed that compared with placebo, receiving niraparib significantly prolonged the median progression-free survival (PFS) of patients, which was 24.8 months compared with 8.3 months.
Among the patients with gBRCA mutation, the median PFS of niraparib treatment was not reached at 10.8 months compared with the placebo group, indicating that the time to relapse was significantly delayed; in patients without gBRCA mutation, the median PFS was 19.3 months compared with placebo Group 8.3 months.
In addition, although overall survival data were immature (mortality rates were 14.5% in the niraparib group and 21.7% in the placebo group, respectively), the niraparib-treated group showed a trend toward superiority at the time of data cutoff.
Different from the previously completed PRIMA, an international phase III clinical study of niraparib for first-line maintenance treatment of ovarian cancer, this PRIME study prospectively evaluated the individualized starting dose of niraparib in addition to all Chinese patients. Efficacy and safety of maintenance therapy with laparib, regardless of patient biomarker status and postoperative residual disease.
The individualized starting dose used in the study means that, except for patients with a baseline body weight of 77 kg and above and a platelet count of 150K/μL or greater, the starting dose is 300 mg, and the rest of the patients are treated with a starting dose of 200 mg.
The study found that the safety of niraparib maintenance therapy improved with individualized starting doses prospectively applied to all patients.
In prospective, individualized starting dose-based maintenance therapy with niraparib, less than 7% of patients discontinued treatment due to adverse events, the highest rate of all PARP inhibitors currently used in first-line maintenance therapy for ovarian cancer stage III lowest in clinical studies.
Compared with the fixed starting dose of 300 mg in international clinical studies, the individualized starting dose reduced the incidence of hematological adverse events.
Grade 3 or greater hematologic adverse events, such as decreased neutrophil count, anemia, and decreased platelet count, occurred in 17.3% versus 1.6% and 18.0% of patients in the niraparib-treated and placebo groups, respectively. Compared with 1.6%, 14.1% compared with 0.8%.
Innovative medicine? Catalogue of medical insurance, more first-line maintenance therapy for newly diagnosed patients is expected to benefit
Ovarian cancer is called "the king of women's cancer" and "the silent invisible killer".
The latest data from the Global Cancer Statistical Report shows that ovarian cancer is one of the gynecological tumors with the highest incidence in China. There are more than 55,000 new cases and 37,000 deaths in China each year, accounting for about 18% of the global new cases and deaths.
"Currently, PARP inhibitor maintenance therapy has become an indispensable and important part of the whole management of ovarian cancer. From the treatment concept to clinical practice, the treatment pattern of ovarian cancer has changed, and it has entered the standard model of 'surgery + chemotherapy + maintenance therapy' It is a huge progress to make long-term remission possible." Wu Lingying said, in fact, compared with foreign countries, there is still some gap in the proportion of ovarian cancer patients in my country who receive PARP inhibitor maintenance therapy, especially the first-line patients with newly diagnosed patients. The proportion of maintenance therapy is still less than half, and the proportion of patients without BRCA mutation receiving first-line maintenance therapy is relatively low.
This restricts the improvement of the overall survival rate of ovarian cancer to a certain extent.
In this regard, experts pointed out that there are two reasons.
First, in previous international clinical studies, the data of patients without BRCA mutations, especially HRD-negative patients were relatively unsatisfactory, but the data of the PRIME study in the Chinese population further confirmed that niraparib monotherapy maintenance treatment, regardless of patient biomarkers Regardless of the status, the progression-free survival of the patients was improved.
This is undoubtedly a shot in the arm for clinical experts and the majority of patients, which will rewrite the current treatment situation.
"Secondly, for newly diagnosed advanced ovarian cancer patients, only patients with BRCA mutation who received maintenance therapy with PARP inhibitors in the past can be reimbursed by medical insurance, but these patients only account for 15% to 25%, and the vast majority of newly diagnosed ovarian cancer patients Cancer patients cannot benefit from medical insurance reimbursement, so many patients miss the precious opportunity of first-line maintenance treatment. This year's medical insurance catalog update has actually included the reimbursement of first-line maintenance treatment for the entire population, which is another good news." Wu Lingying Say.
It is worth noting that in the new version of the National Medical Insurance Drug List, the PARP inhibitor niraparib for first-line maintenance treatment of ovarian cancer has been included in the national medical insurance reimbursement regardless of the patient's biomarker status.
Taking local patients in Beijing as an example, receiving niraparib maintenance treatment, the average monthly cost of individuals after reimbursement is reduced to a minimum of about 1,400 yuan, which is more than 20,000 yuan less than before medical insurance.
"For ovarian cancer patients, especially newly diagnosed ovarian cancer patients, regardless of whether there is a BRCA mutation, PARP inhibitors should be considered as first-line maintenance therapy on the basis of surgery and standard platinum-containing chemotherapy, so as to maximize the delay of tumor recurrence. , no longer passively waiting anxiously." Wu Lingying pointed out that with the release of PRIME research data with high-quality and evidence-based medicine, and the improved availability of innovative drugs brought about by the medical insurance policy, more ovarian cancer patients will be able to Use new and good drugs as soon as possible to achieve long-term standardized treatment.
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