Ovarian cancer is a common gynaecological malignancy still remaining a challenge to treat. The objective of this study was to evaluate the impact of platinum dose reduction and chemotherapy delays on progression free survival and overall survival in patients with stage III ovarian cancer and to analyze reasons for such chemotherapy scheme modifications. Medical records of patients with FIGO stage III ovarian cancer were reviewed. Inclusion criteria involved FIGO stage III epithelial ovarian carcinoma; cytoreductive surgery performed and 6 courses of platinum-based chemotherapy completed; no neoadjuvant chemotherapy applied; and no history of previous malignancies. Progression free survival and overall survival were analyzed using Kaplan-Meier and Cox proportional hazards models. Significant 3.3 times higher death risk in patients who experienced only chemotherapy delays compared with patients who did not experience any chemotherapy scheme modifications was established (HR = 3.3, 95% Cl: 1.2 – 8.5, p = 0.016). Increased death risk in patients who experienced only chemotherapy delays compared with patients who experienced both chemotherapy delays and platinum dose reduction was also established (HR = 2.3, 95% Cl: 1.1 – 4.8, p = 0.021). Main reasons for chemotherapy scheme modifications (in decreasing order) were the following: neutropenia, modifications with no objective medical reasons, renal disorders, anaemia, poor performance status, gastrointestinal symptoms and neuropathy. Overall survival in patients who experienced chemotherapy scheme modifications with no objective medical reasons was non-inferior than in patients who did not experience any chemotherapy scheme modifications. Chemotherapy delays in patients with FIGO stage III ovarian cancer caused lower overall survival. The most common reason for chemotherapy scheme modifications was neutropenia.
Background: Locally advanced rectal cancer (LARC) treatment selection between neoadjuvant intensified chemotherapy (NIC) and standard chemoradiotherapy (CRT) lacks validated predictive biomarkers. Interleukin-1β (IL1B) polymorphisms modulate IL-1β expression and may influence treatment-specific outcomes through tumor microenvironment remodeling. Methods: In this prospective, single-center, randomized, open-label noninferiority trial (NCT05378919), 150 patients with stage II–III rectal cancer were randomized 1:1 to NIC (FOLFOX4, 8 cycles; n=68) or CRT (50 Gy/25 fractions with concurrent fluoropyrimidine; n=82). The primary endpoint was 5-year disease-free survival (DFS; noninferiority margin HR ≤1.29, NIC vs. CRT). IL1B rs1143634 and rs16944 were genotyped by TaqMan assay. Treatment–genotype interactions were assessed using Cox regression with multiplicative interaction terms. Results: Noninferiority was not demonstrated: 5-year DFS was 54.4% (NIC) versus 68.1% (CRT) in the ITT population (HR 1.52, 95% CI 0.90–2.56; p=0.114), with the upper CI bound exceeding the prespecified margin of 1.29. Per-protocol DFS was significantly inferior for NIC (62.5% vs. 82.1%; HR 2.27, 95% CI 1.06–4.76; p=0.029). Overall survival and cancer-specific survival (CSS) did not differ significantly between arms. A statistically significant treatment–genotype interaction was identified for rs1143634 in CSS (interaction p<0.001): T-allele carriage (CT+TT) was associated with inferior CSS exclusively in the NIC arm (HR 4.84, 95% CI 1.04–22.43; p=0.044), with no prognostic effect in the CRT arm (HR 0.69; p=0.494). A DFS interaction was also significant (p=0.047). rs16944 showed a borderline CSS interaction (p=0.082). Conclusions: NIC (FOLFOX4) did not achieve DFS noninferiority versus CRT in unselected LARC patients. IL1B rs1143634 demonstrates a treatment-arm-specific prognostic effect on cancer-specific survival, with a highly significant treatment–genotype interaction (p<0.001) identified within a prospective randomized design with prespecified translational hypotheses, satisfying the formal criterion for predictive biomarker classification. Prospective validation in an adequately powered, biomarker-stratified trial is warranted.
Background: According to the majority of retrospective analyses and meta-analyses published in recent years, radical prostatectomy is a more effective treatment method than radical radiotherapy. The objective of this study was to assess whether the treatment method influences the survival of patients with early prostate cancer and to evaluate the impact of patient-dependent and prostate cancer-dependent prognostic factors on the choice of radical treatment method of prostate cancer.Methods: Medical records of selected patients were reviewed. Inclusion criteria involved histologically confirmed prostate adenocarcinoma; localised or locally advanced prostate cancer diagnosed in 2008-2012; no distant metastases at the time of initial diagnosis; medical records maintain comprehensive data on treatment and follow-up. The influence of prognostic factors on the choice of treatment method was assessed by making comparisons between groups using the Chi-square test.Results: More favorable prognostic factors were found in the RP treatment group compared to the RT treatment group: patients aged 60 years and younger accounted for 35% in the RP group, and 18% - in the RT group, with increasing age the number of RP decreased and the number of RT increased (p < 0.001); score of 3-4 points of CCI was set in 36% patients in the RP group, and 6% - in the RT group, with increasing CCI score, the number of RP decreased and the number of RT increased (p < 0.001); baseline PSA level of 10 ng/ml and less was found in 67% patients in the RP group, and 52% - in the RT group, with increasing PSA level, the number of RP decreased and the number of RT increased (p < 0.001). Gleason score did not influence the choice of treatment method (p = 0.24).Conclusions: Prognostic factors of localised or locally advanced prostate cancer influenced the choice of treatment method. In case of more favorable prognostic factors, radical prostatectomy was more often chosen.