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Simple Summary: Patients with multiple myeloma (MM) who become refractory to three or more lines of therapy (RRMM patients) have few valid therapeutic alternatives. Among them, drugs directed against the BCMA antigen expressed in plasma cells are very appealing. Belantamab-mafodotin (belamaf) is the first antibody-drug conjugate against BCMA ready for clinical use. In this paper, we report the Spanish experience of belamaf monotherapy in 156 patients with RRMM. The overall response rate was 41.8%, with 39.8% of patients achieving a partial response or better. Median progression-free survival was 3.61 months, but interestingly, it increased to 14.47 months in patients achieving a minimal response or better. Treatment was well tolerated, ocular events being the most reported toxicity (87.9%; grade ≥ 3, 33.7%), but only two patients discontinued treatment due to side effects. Overall, our results confirm the safety and efficacy of belamaf in this poor prognosis subset of patients. Belantamab-mafodotin (belamaf) is a novel antibody-drug conjugate targeting B-cell maturation antigen that showed anti-myeloma activity in patients with relapsed and refractory multiple myeloma (RRMM). We performed an observational, retrospective, and multicenter study aimed to assess the efficacy and safety of single-agent belamaf in 156 Spanish patients with RRMM. The median number of prior therapy lines was 5 (range, 1–10), and 88% of patients were triple-class refractory. Median follow-up was 10.9 months (range, 1–28.6). The overall response rate was 41.8% (≥CR 13.5%, VGPR 9%, PR 17.3%, MR 2%). The median progression-free survival was 3.61 months (95% CI, 2.1–5.1) and 14.47 months (95% CI, 7.91–21.04) in patients achieving at least MR (p < 0.001). Median overall survival in the entire cohort and in patients with MR or better was 11.05 months (95% CI, 8.7–13.3) and 23.35 (NA-NA) months, respectively (p < 0.001). Corneal events (87.9%; grade ≥ 3, 33.7%) were the most commonly adverse events, while thrombocytopenia and infections occurred in 15.4% and 15% of patients, respectively. Two (1.3%) patients discontinued treatment permanently due to ocular toxicity. Belamaf showed a noticeably anti-myeloma activity in this real-life series of patients, particularly among those achieving MR or better. The safety profile was manageable and consistent with prior studies. [ABSTRACT FROM AUTHOR]

Breast cancer is one of the most frequent malignancies. The aim of the article is to analyse the cost-utility ratio and budgetary impact of talazoparib treatment for patients with locally advanced or metastatic gBRCA + breast cancer from the perspective of the Spanish National Health System. Analyses were based on the EMBRACA clinical trial and the model was constructed according to " partitioned survival analysis ". Two scenarios were considered in order to compare talazoparib with the alternatives of capecitabine, vinorelbine and eribulin: 1. Chemotherapy in patients pre-treated with anthracyclines/taxanes and, 2. A second- and subsequent-line treatment option. Treatment types following relapse were recorded in the mentioned clinical trial. The effectiveness measure used was quality-adjusted life years (QALY). The average health cost of patients treated at 43 months with talazoparib was 84,360.86€, whilst current treatment costs were 26,683.90€. The effectiveness of talazoparib was 1.93 years of survival (1.09 QALY) relative to 1.58 years (0.83 QALY) in the treatment group. The incremental cost-utility ratio was 252,420.04€/QALY. This represents the additional cost required to earn an additional QALY when changing from regular treatment to talazoparib. Regarding budgetary impact, the number of patients susceptible to receiving treatment with between 94 and 202 talazoparib was estimated, according to scenario and likelihood. The 3-year cost difference was between 6.9 and 9 million euros. The economic evaluation conducted shows an elevated incremental cost-utility ratio and budgetary impact. Taking these results into account, the price of talazoparib would have to be lower than that taken as a reference to reach the cost-utility thresholds. • As far as the authors know, this paper is the first economic evaluation of iPARP in advanced/metastatic breast cancer. • Talazoparib does not extend the median survival time compared to capecitabine, vinorelbine and eribulin. • As for low survival improvement of talazoparib, it should be used with caution in patients with breast cancer BRCA mutation. [ABSTRACT FROM AUTHOR]

Simple Summary: Metastatic colorectal cancer is common and complicated to treat. The first choice of treatment is guided by the genetics of the patients (RAS mutation status) and the location of their primary tumor. However, real-world information on what treatments are actually being used and the survival benefits of these patient-guided treatments in Spain is lacking, so we aimed to determine this. We found that, in general, treatment choice was guided by primary tumor location and mutation status, with mutation status being the more influential characteristic. In addition, non-mutated RAS or left-sided tumors were predictive of longer survival times. We hope the results of this study may serve as a useful benchmark for future studies and assist practicing oncologists in selecting appropriate treatments for their patients. The retrospective, observational RWD-ACROSS study analyzed disease characteristics, systemic treatment, and survival in patients with metastatic colorectal cancer (mCRC) in Spain. In total, 2002 patients were enrolled (mean age 65.3 years; 62.7% male). Overall median overall survival (OS) was 26.72 months, and was longer in patients with left-sided tumors (28.85 vs. 21.04 months (right-sided tumors); p < 0.0001) and in patients receiving first-line anti-epidermal growth factor receptor (EGFR) treatment (31.21 vs. 26.75 (anti-vascular endothelial growth factor (VEGF) treatment) and 24.45 months (chemotherapy); p = 0.002). Overall median progression-free survival (PFS) was 10.72 months and was longer in patients with left-sided tumors (11.24 vs. 9.31 months (right-sided tumors); p < 0.0001), and in patients receiving either first-line anti-EGFR or anti-VEGF (12.13 and 12.00 vs. 8.98 months (chemotherapy); p < 0.001). PFS was longer with anti-VEGF treatment in patients with right-sided tumors and wild-type RAS (11.24 vs. 8.78 (anti-EGFR) and 7.83 months (chemotherapy); p = 0.025). Both anti-EGFR and anti-VEGF produced longer PFS in patients with left-sided tumors and wild-type RAS than chemotherapy alone (12.39 and 13.14 vs. 9.83 months; p = 0.011). In patients with left-sided tumors and mutant RAS, anti-VEGF produced a longer PFS than chemotherapy alone (12.36 vs. 9.34 months; p = 0.001). In Spain, wild-type RAS or left-sided mCRC tumors are predictive of longer survival times. [ABSTRACT FROM AUTHOR]

Simple Summary: Colorectal cancer is one of the leading neoplasms in mortality worldwide. Recent studies suggest that vitamin D might influence the development of colorectal cancer and its prognosis. Furthermore, vitamin D activity might be influenced by the presence of single nucleotide polymorphisms in the genes involved in its metabolism. Thus, the aim of this study was to evaluate the influence of 13 SNPs in the vitamin D metabolic pathway on colorectal cancer survival. The results of the study showed that variants in VDR, CYP24A1, and GC genes are associated with a lower survival rate. Several studies have suggested that single nucleotide polymorphisms (SNPs) related to vitamin D metabolism may affect CRC carcinogenesis and survival. The aim of this study was to evaluate the influence of 13 SNPs involved in the vitamin D metabolic pathway on CRC survival. We conducted an observational retrospective cohort study, which included 127 Caucasian CRC patient from the south of Spain. SNPs in VDR, CYP27B1, CYP2R1, CYP24A1, and GC genes were analyzed by real-time polymerase chain reaction. Progression-free survival (PFS) and overall survival (OS) were assessed. Cox regression analysis adjusted for metastasis, age of diagnosis, stage (IIIB, IV or IVB), ECOG score (2–4), lymph node involvement, adjuvant chemotherapy, and no family history of CRC showed that the VDR ApaI (p = 0.036), CYP24A1 rs6068816 (p < 0.001), and GC rs7041 (p = 0.006) were associated with OS in patients diagnosed with CRC, and CYP24A1 rs6068816 (p < 0.001) was associated with PFS adjusted for metastasis, age of diagnosis, stage (IIIB, IV or IVB), ECOG score (2–4), lymph node involvement, adjuvant chemotherapy, and no primary tumor resection. The rest of the SNPs showed no association with CRC survival. Thus, the SNPs mentioned above may have a key role as prognostic biomarkers of CRC. [ABSTRACT FROM AUTHOR]

Objective: To study immune-related adverse events (irAEs) in non-small cell lung cancer (NSCLC) patients treated with nivolumab, as well as to assess whether these reactions could be predictors of further effectiveness of therapy. Methods: Retrospective, observational and longitudinal study. All NSCLC patients who received nivolumab between February 2015-May 2020 were included. In terms of safety, irAEs and their severity were registered and to evaluate the effectiveness, overall survival (OS) and progression free survival (PFS) were calculated. Results: 75 patients were included. 32 patients (43%) were reported irAES. Mainly the irAEs affected the skin (36%). Followed by pneumonitis (20%), gastrointestinal reactions (12%), endocrine (12%) and hepatitis (12%). Regarding severity, 92% were moderate. The median PFS was 9.49 months on the group with irAEs versus 1.99 months on the group without irAEs group (p < 0.0001). The median OS was 17.44 months versus 7.67 months respectively (p = 0.0001). According to the incidence of irAEs developed (= > 2 vs. 1 vs. 0), the median PFS was 20.53 versus 5.35 versus 1.99 months respectively (p < 0.0001). The median OS was 23.41 versus 15.80 versus 7.67 months, respectively (p = 0.0002) Conclusion: In a significant number of patients irAEs occur, generally of grade 1–2 severity, affecting mainly the skin, lungs and gastrointestinal system. We confirm that the development of irAEs in patients with NSCLC treated with nivolumab is a strong predictor of treatment effectiveness in both PFS and OS, with statistically significant results. On those patients who experience two or more immunorelated adverse events the greatest benefit has been observed. [ABSTRACT FROM AUTHOR]

Purpose: To analyze if perioperative and oncologic outcomes with stenting as a bridge to surgery (SEMS-BS) and interval colectomy performed by acute care surgeons for left-sided occlusive colonic neoplasms (LSCON) are non-inferior to those obtained by colorectal surgeons for non-occlusive tumors of the same location in the full-elective context. Methods: From January 2011 to January 2021, patients with LSCON at University Regional Hospital in Málaga (Spain) were directed to a SEMS-BS strategy with an interval colectomy performed by acute care surgeons and included in the study group (SEMS-BS). The control group was formed with patients from the Colorectal Division elective surgical activity dataset, matching by ASA, stage, location and year of surgery on a ratio 1:2. Stages IV or palliative stenting were excluded. Software SPSS 23.0 was used to analyze perioperative and oncologic (defined by overall -OS- and disease free -DFS-survival) outcomes. Results: SEMS-BS and control group included 56 and 98 patients, respectively. In SEMS-BS group, rates of technical/clinical failure and perforation were 5.35% (3/56), 3.57% (2/56) and 3.57% (2/56). Surgery was performed with a median interval time of 11 days (9–16). No differences between groups were observed in perioperative outcomes (laparoscopic approach, primary anastomosis rate, morbidity or mortality). As well, no statistically significant differences were observed in OS and DFS between groups, both compared globally (OS:p < 0.94; DFS:p < 0.67, respectively) or by stages I–II (OS:p < 0.78; DFS:p < 0.17) and III (OS:p < 0.86; DFS:p < 0.70). Conclusion: Perioperative and oncologic outcomes of a strategy with SEMS-BS for LSCON are non-inferior to those obtained in the elective setting for non-occlusive neoplasms in the same location. Technical and oncologic safety of interval colectomy performed on a semi-scheduled situation by acute care surgeons is absolutely warranted. [ABSTRACT FROM AUTHOR]