According to a post-hoc analysis of RECOURSE trial, metastatic colorectal cancer (mCRC) trifluridine/tipiracil treated patients with good prognostic characteristics (GPC) have higher overall survival (OS) and progression-free survival (PFS), when compared with those with poor prognostic characteristics (PPC). Phase III SUNLIGHT trial demonstrated an improvement in outcomes with the association of bevacizumab. This study aimed to evaluate the impact of trifluridine/tipiracil plus bevacizumab treatment in PFS and OS of patients with mCRC, stratified according to both prognostic groups from RECOURSE trial, using real-world data from patients that received both combination and monotherapy. Single-centre, retrospective cohort study of mCRC patients who started trifluridine/tipiracil between January 2020 and November 2022. Patients were divided into two subgroups (combination with bevacizumab and monotherapy) and further stratified in GPC [low tumour burden (less than 3 metastatic sites) and indolent disease (≥18 months from first metastasis)] and PPC [high tumour burden (3 or more metastasis sites) and/or aggressive disease ( < 18 months since the first metastasis)]. Statistical analysis was performed with Kaplan Meyer curves and univariate Cox Regression with α=0,05. In the trifluridine/tipiracil monotherapy subgroup (n=32), 71% were male, with median age 66 (30-82). Median number of metastases was 2 (1-4) and 53% had PPC. In the combination group (n=14), 57% were male, with median age 64 (49-74). Median number of metastases was 2 (1-4) and 50% had PPC. Overall, PFS was 3.29 months (IC95% 1.24-5.33) and 2.40 months (IC95% 1.69-3.11) for the combination and monotherapy, respectively (HR 0.36, p=0.35). Patients with GPC had PFS of 5.72 months (IC95% 3.40-8.03) with the combination and 3.91 months (IC95% 2.60-5.22) with monotherapy (HR 0.94, p=0.91). In the PPC group, PFS reached 3.09 months (IC95% 1.49-4.70) with the combination and 1.15 months (IC95% 0.66-1.64) with the monotherapy (HR 0.27, p=0.01). Median OS was not reached for both GPC and PPC patients in the combination cohort. In our real-world data of the SUNLIGHT trial, patients had increased PFS with the combination therapy. Patients with GPC had more benefit from both monotherapy and combination, when compared with those with PPC. Despite the lower number of patients and follow-up time in the combination cohort, addition of bevacizumab to trifluridine/tipiracil benefited all patients independently of disease burden or aggressiveness, although statistical significance in GPC patients was not reached.

Abstract Background Glioblastoma (GBM) is the most common and aggressive primary malignant brain tumor in adults, and it is associated with a poor prognosis in the elderly. The current standard of care for newly diagnosed GBM is maximal surgical resection, followed by radiotherapy plus concomitant and adjuvant temozolomide (TMZ). In elderly patients with GBM, short-courses of radiotherapy with TMZ are used. Material and Methods We performed a single-center retrospective analysis of elderly GBM patients treated from 2013 to 2020. The primary endpoint was to evaluate progression free survival (PFS) and overall survival (OS) according to treatment received (TMZ and standard radiotherapy (60 Gy over a period of 6 weeks) vs TMZ and short-course radiotherapy (40 Gy in 15 fractions)). Secondary endpoints were analysis of population demographics and major toxicities associated to treatment. Results Twenty-two patients were identified. The median age was 72 years (range 65- 80), 18 (85.7%) patients were in ECOG-PS 0-1, 12 (57.1%) were males and all patients had undergone partial or complete resection surgery. Eleven (52.4%) patients received TMZ and standard radiotherapy and 10 (47.6%) patients received TMZ and short-course radiotherapy. Three (14.3%) patients had complete remission, 11 (52.4%) patients had partial response, 2 (9.5%) patients presented stable disease and 5 (23.8%) patients had disease progression. Median OS was 9 months (95% CI, 3.6 to 14.4) with TMZ with standard radiotherapy and 8 months (95% CI, 1.8 to 14.2) with TMZ and short-course radiotherapy (p=0.322). Median PFS was 5 months (95% CI, 2.8 to 7.2) with TMZ with standard radiotherapy and 6 months (95% CI, 3.1 to 8.9) with TMZ and short-course radiotherapy (p=0.944). Most common toxicities were hematological, with 5 (23.8%) patients presented thrombocytopenia grade 2 or higher. Five (23.8%) patients presented grade 3/4 toxicities (2 (9.5%) patients presented thrombocytopenia grade 4, 1 (4.8%) patient presented thrombocytopenia grade 3, and 2 (9.5%) patients presented anemia grade 3. Conclusion The prognosis of GBM remains poor besides standard therapy. TMZ and short-course radiotherapy should be an option in elderly patients due to its non-inferiority. Elderly patients should undergo a careful geriatric evaluation before starting treatment.

Neuroendocrine neoplasms (NENs) are a rare group of tumors with different prognosis and responses to therapy. Their heterogeneity is dependent on the site of origin, morphology, and proliferation rate. The chemotherapy capecitabine and temozolomide based regimen (CAPTEM) has shown interesting results in the treatment of these tumors. We analyzed “real-world” data on the use of CAPTEM in patients with metastatic NENs. Retrospective analysis of patients with metastatic NENs treated with CAPTEM chemotherapy between January 2010 and December 2020 was performed. Patients received capecitabine at 750 mg/m2 orally twice daily on days 1-14 and temozolomide 200 mg/m2 orally once daily on days 10-14 every 28 days. The clinical variables and survival data were collected. CAPTEM therapy was administered to 23 patients with a median age of 56 years (range 23-79 years). Primary tumor sites were pancreas 17 (74%), small bowel 2 (8.7%), large bowel 2 (8.7%), gastric 1 (4.3%) and unknown 1 (4.3%). Of the 23 patients, 18 (78.3%) underwent prior treatment. Mean Ki-67 index was 10% (range: 1-25%). The median overall survival (mOS) and median progression-free survival (mPFS) were 65.2 months (43-87.3 months) and 37.6 months (17.7-57.6 months), respectively. Among patients who primary tumor was non-pancreatic, the mPFS was longer than mPFS of patients with pancreatic tumors (61.7 months versus 20.1 months), but with no statistically significant difference between the groups (P = 0.08). The clinical benefit (responders and stable disease) was 78.3% at 6 months. Mild adverse events (grade 1 and 2) included nausea, vomiting, and thrombocytopenia. There were no grade 3 or 4 toxicities. Our experience confirms that CAPTEM is associated with encouraging PFS and OS data in patients with NENs. It is a well-tolerated oral regimen with a good safety profile.