Lancet Sub -journal: Abbit Dragon+Olapali treatment of prostate cancer can significantly improve PFS

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Lancet Sub -journal: Abbit Dragon+Olapali treatment of prostate cancer can significantly improve PFS

▎ Clinical issue:

Compared with the treatment of placebo Gamallon, the impact of Ora Paliga Aibi Dragon treatment of metastatic resistance on pain and health -related life quality (HRQOL) is unclear.

A phase II clinical trial from the Lancet sub -magazine shows that the addition of Olapali during the treatment of metastatic removal resistance to prostate cancer can significantly improve the no progressive survival period (PFS), but there is no pain or HRQOL in terms of pain or HRQOL. Significant differences.

▎ Research plan:

(1) Incident in the standard: age is 18 years old or above, suffering from metastatic removal resistance prostate cancer, and patients who have received too many casis and another kind of chemotherapy; : Although the male hormone deprivation treatment is performed, the concentration of the prostate special antigen (PSA) is still increasing or there are signs of other diseases. The concentration of serum testosterone reaches the level (≤50ng/dl), and in bone scanning, CT or or CT or There are at least one metastatic lesion on MRI; a total of 171 people are included, 29 people and 142 people are selected;

(2) Eligible patients are randomly allocated (1: 1), and a group of oral Olapali (300mg, twice a day) add oral Abbit dragon (1000mg once a day) and oral Pennone or Pannini Songlong (5mg, twice a day), and another group of uniforms with Aubi Dragon (1000mg, once a day) and Domanone or Pennarin (5mg, twice a day);

(3) In the case of not layered, random grouping by using interactive voice or network response system; allocate a random treatment package ID number to each eligible patient in order;

(4) Pre-specified exploratory patients report the end of the report of HRQOL; the patient is required to complete the concise pain meter (BPI-SF), the most serious bone pain, cancer, cancer, cancer, and cancer at the baseline, 4th weeks, 8th weeks, and 12th week. Treatment function assessment-prostate (FACT-P) questionnaire, and EUROQOL-5 five-dimensional 5D (EQ-5D-5L) evaluation, then once every 12 weeks until the treatment is suspended; the pre-stipulated ending is the most serious pain in BPI-SF the most serious pain The most serious bone pain and FACT-P overall results index (Toi) meter scores from the baseline, the most severe pain and the most severe bone pain deterioration of BPI-SF, and the EQ-5D-5L pain and discomfort areas Evaluate;

(5) All analysis is exploratory, and in a complete analysis (all randomly distributed patients, including patients with random distribution but later did not receive research and treatment), except for the analysis of the average baseline and baseline change. To this end, this study uses people with valid baseline and at least one baseline to analyze.

▎ Main discovery:

(1) BPI-SF's most severe pain, the most severe bone pain, and FACT-P toI of the two groups of BPI-SF have maintained stable average daily multiplication from the baseline;

(2) In all visits, the FACT-P TOI of the Olapaliga Aibi Dragon Group has a average change from the baseline to -0.10 (95%CI-2.50-2.71), the placebo Gami Abbit Dragon group is -1.20 (95%CI-4.15-1.74) (Differences 1.30, 95%CI is -2.70-5.30; P = 0.52); P = 0.52);

(3) The time of the two groups of pain deteriorated (BPI-SF's most serious pain HR is 0.90, 95%CI 0.62-1.32, P = 0.30; the most severe bone pain HR is 0.85, 95%CI 0.59-1.22, P = 0.18 );

(4) From the baseline to the 48th week, the improvement rate of the two groups of patients in EQ-5D-5L pain and discomfort is similar; compared with the placebo Gami Dragon group, the patient's report on the Ara Paliga Abbele Group reported The proportion of improvement is higher.

▎ Looking out:

Compared with the placebo Gami Dragon, the improvement of survival benefits observed when Orapari and Abdo Dragon are used in use did not lead to different HRQOL; these results need to be verified in 3 phase studies.

references:

[1] https://www.thelancet.com/journals/lanonc/article/piis1470-2045 (22) 00498-3/fullText

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