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Background No widely used prognostic tool exists to demonstrate the benefit of oxaliplatin plus 5-fluorouracil/leucovorin (FOLFOX4) in patients with advanced hepatocellular carcinoma (HCC). We aimed to establish a prognostic score and demonstrate the real-world efficacy of FOLFOX4 chemotherapy in Thai patients. Methods Between August 2017 and December 2021, we identified 58 FOLFOX4-treated patients with HCC. Overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) were assessed. The prognostic score was constructed by stepwise Cox proportional hazards regression analysis to select variables for the best model with the lowest Akaike information criterion from all potential variables. Results Forty-four patients (76%) received FOLFOX4 as first-line therapy. The ORR in the entire cohort was 8.6%, and the disease control rate was 29.3%. The PFS and OS were 3.7 and 4.8 months, respectively. Four clinically relevant variables were included in the new prognostic score to predict 6-month OS: L, the presence of lung metastasis; A, alcoholic cirrhosis; B, elevated total bilirubin level; and S, sorafenib-naïve status. Using the LABS score, patients were classified into low-, intermediate-, and high-risk groups, demonstrating OS values of 9.3, 4.2, and 2.1 months, respectively ( p  < 0.0001). The C-index and area under the receiver-operating characteristic curve of the score were 0.71 and 0.73, respectively. Conclusions The proposed LABS score could discriminate patients who would derive benefit from FOLFOX4 chemotherapy. FOLFOX4 chemotherapy is an option for patients who cannot receive immunotherapy and targeted therapy, particularly those with a low-risk score. However, further validation of this model via larger cohorts is warranted.

Objective Combination fluoropyrimidine-based chemotherapy is the standard first-line treatment for metastatic colorectal cancer (CRC). We performed a propensity score (PS)-based analysis to report our real-world experience with long-term follow-up of this regimen for metastatic CRC. Methods In this retrospective study, 170 patients with newly diagnosed metastatic CRC treated with first-line combination chemotherapy between January 2003 and March 2021 were identified. Cox proportional hazards regression analysis and PS-based approaches with the logistic regression model were adopted, and the results were compared. Results The hazard ratio for overall survival (OS) in the oxaliplatin- and irinotecan-based groups was 0.79 (95% confidence interval = 0.56–1.11), and the median OS times in these groups were 16.8 and 13.0 months, respectively. The median time to progression (TTP) for these regimens were 9.0 and 8.9 months, respectively. The objective response rates for the oxaliplatin- and irinotecan-based groups were 42.7% and 34.6%, respectively. OS and TTP did not differ between these regimens in all PS matching models. Conclusions First-line treatment using fluoropyrimidine-based chemotherapy regimens in combination with oxaliplatin or irinotecan in patients with metastatic CRC provided comparable efficacy and tolerable toxicity profiles in a real-world setting with long-term follow-up.

Phosphatidylinositol 3-kinase (PI3K) pathway activation in squamous cell carcinoma of the head and neck contributes to treatment resistance and disease progression. Buparlisib, a pan-PI3K inhibitor, has shown preclinical antitumour activity and objective responses in patients with epithelial malignancies. We assessed whether the addition of buparlisib to paclitaxel improves clinical outcomes compared with paclitaxel and placebo in patients with recurrent or metastatic squamous cell carcinoma of the head and neck. In this multicentre, randomised, double-blind, placebo-controlled phase 2 study (BERIL-1), we recruited patients aged 18 years and older with histologically or cytologically confirmed recurrent and metastatic squamous cell carcinoma of the head and neck after disease progression on or after one previous platinum-based chemotherapy regimen in the metastatic setting. Eligible patients were enrolled from 58 centres across 18 countries and randomly assigned (1:1) to receive second-line oral buparlisib (100 mg once daily) or placebo, plus intravenous paclitaxel (80 mg/m2 on days 1, 8, 15, and 22) in 28 day treatment cycles. Randomisation was done via a central patient screening and randomisation system with an interactive (voice and web) response system and stratification by number of previous lines of therapy in the recurrent and metastatic setting and study site. Patients and investigators (including local radiologists) were masked to treatment assignment from randomisation until the final overall survival analysis. The primary endpoint was progression-free survival by local investigator assessment per Response Evaluation Criteria In Solid Tumors (version 1.1) in all randomly assigned patients. Efficacy analyses were done on the intention-to-treat population, whereas safety was analysed in all patients who received at least one dose of study drug and had at least one post-baseline safety assessment according to the treatment they received. This trial is registered with ClinicalTrials.gov, number NCT01852292, and is ongoing but no longer enrolling patients. Between Nov 5, 2013, and May 5, 2015, 158 patients were enrolled and randomly assigned to receive either buparlisib plus paclitaxel (n=79) or placebo plus paclitaxel (n=79). Median progression-free survival was 4·6 months (95% CI 3·5–5·3) in the buparlisib group and 3·5 months (2·2–3·7) in the placebo group (hazard ratio 0·65 [95% CI 0·45–0·95], nominal one-sided p=0·011). Grade 3–4 adverse events were reported in 62 (82%) of 76 patients in the buparlisib group and 56 (72%) of 78 patients in the placebo group. The most common grade 3–4 adverse events (occurring in ≥10% of patients in the buparlisib group vs the placebo group) were hyperglycaemia (17 [22%] of 76 vs two [3%] of 78), anaemia (14 [18%] vs nine [12%]), neutropenia (13 [17%] vs four [5%]), and fatigue (six [8%] vs eight [10%]). Serious adverse events (regardless of relation to study treatment) were reported for 43 (57%) of 76 patients in the buparlisib group and 37 (47%) of 78 in the placebo group. On-treatment deaths occurred in 15 (20%) of 76 patients in the buparlisib group and 17 (22%) of 78 patients in the placebo group; most were caused by disease progression and none were judged to be related to study treatment. On the basis of the improved clinical efficacy with a manageable safety profile, the results of this randomised phase 2 study suggest that buparlisib in combination with paclitaxel could be an effective second-line treatment for patients with platinum-pretreated recurrent or metastatic squamous cell carcinoma of the head and neck. Further phase 3 studies are warranted to confirm this phase 2 finding. Novartis Pharmaceuticals Corporation.

Background: The treatment landscape for advanced hepatocellular carcinoma (HCC) has evolved significantly recently; however, access to novel agents remains limited because of high costs. This study aimed to evaluate the systemic treatment patterns and survival outcomes for advanced HCC across different systemic treatment sequences under real-world resource constraints. Methods: This retrospective study was conducted at a tertiary center in Southern Thailand. The medical records of patients (n = 330) with advanced HCC treated with systemic therapy between 2010 and 2024 were reviewed. Outcomes included overall survival (OS), progression-free survival (PFS), and objective response rate (ORR). Prognostic factors for OS were investigated. Results: First-line therapies included tyrosine kinase inhibitor (TKI; 69.7%), chemotherapy (23.3%), immunotherapy (IO)/targeted therapy (3.6%), dual IO (1.8%), and IO monotherapy (1.5%). The median OS, PFS, and ORR for each cohort were 7.2, 5.2, 10.9, 8.5, and 8.6 months; 3.94, 3.22, 3.48, 6.19, and 2.69 months; and 9.6%, 10.4%, 16.7%, 0%, and 20.0%, respectively. OS improved with increasing lines of therapy (4.5, 12.2, 19.4, and 40.7 months for one to four lines, respectively). Portal vein tumor thrombus, ascites, elevated bilirubin level, high alpha-fetoprotein level, and poor Eastern Cooperative Oncology Group performance status were associated with poor prognosis; multiple treatment lines and overweight status were associated with improved OS. Conclusions: In this large real-world cohort, TKIs remained the mainstay effective treatment option because of limited access to IO-based regimens. Sequential systemic therapy significantly improved survival, emphasizing the importance of preserving treatment eligibility and multidisciplinary team involvement. Chemotherapy could be considered a viable option in resource-limited settings.

Background The current standard first-line treatment for hormone receptor-positive/human epidermal growth factor receptor 2 negative (HR + /HER2 −) advanced breast cancer (ABC) is a combination of aromatase inhibitor (AI) plus CDK4/6 inhibitors (CDK4/6i). Direct comparison trials of different CDK4/6i are scarce. This real-world study compared the effectiveness of first-line AI plus ribociclib versus palbociclib. Methods This multicenter retrospective cohort study, conducted in six cancer centers in Thailand, enrolled patients with HR + /HER2 − ABC treated with first-line AI, and either ribociclib or palbociclib. Propensity score matching (PSM) was performed. The primary endpoint was overall survival (OS). Secondary endpoints included progression-free survival (PFS), overall response rate (ORR), time to chemotherapy (TTC), and adverse events. Results Of the 250 patients enrolled, 134 patients with ribociclib and 49 patients with palbociclib were captured after PSM. Baseline characteristics were well-balanced between groups. Median PFS in patients receiving ribociclib and palbociclib were 27.9 and 31.8 months, respectively (hazard ratio: 0.87; 0.55–1.37). The median OS in the AI + ribociclib arm was 48.7 months compared to 59.1 months in the AI + palbociclib arm (hazard ratio: 0.55; 0.29–1.05). The median TTC in the AI + palbociclib group was 56 months, but not reached in the AI + ribociclib group ( p  = 0.42). The ORR of AI + ribociclib and AI + palbociclib were comparable (40.5% vs. 53.6%, p  = 0.29). Patients receiving palbociclib demonstrated a higher proportion of neutropenia compared to those receiving ribociclib, despite a similar dose reduction rate ( p  = 0.28). Hepatitis rate was similar between the ribociclib (21%) and palbociclib groups (22%). Additionally, a low incidence of QT prolongation was observed in both the ribociclib (5%) and palbociclib groups (4%). Conclusion This preliminary analysis of a real-world study demonstrated the comparable effectiveness of ribociclib and palbociclib with AI as an initial therapy for HR + /HER2 − ABC. No statistically significant difference in PFS, OS, and TTC was found in patients treated with AI combined with palbociclib or ribociclib. Longer follow-up and further prospective randomized head-to-head studies are warranted.

Small bowel adenocarcinoma (SBA) is a rare gastrointestinal malignancy with limited evidence guiding systemic treatment in the advanced stages. This study evaluated the effectiveness of palliative chemotherapy and revealed the prognostic factors associated with survival in patients with metastatic or unresectable SBA. We conducted a retrospective cohort study of patients diagnosed with advanced SBA at a single tertiary center in Thailand between 2005 and 2024. The patients were treated with palliative systemic chemotherapy or best supportive care (BSC). Survival outcomes were assessed using Kaplan-Meier estimates and Cox regression analyses. Propensity score-matching (PSM) was performed to adjust for baseline imbalances. This study included 106 patients; of these, 39 (36.8%) received palliative chemotherapy. After 1:1 PSM, 39 matched pairs were analyzed. Chemotherapy significantly improved overall survival (OS) compared with that of the BSC, with a median OS of 10.4 vs 2.6 months (hazard ratio 0.36; 95% confidence intervals 0.22-0.59; <0.001). Among chemotherapy-treated patients, the median progression-free survival was 5.95 months, and the objective response rate was 10.3% overall, increasing to 21.1% among evaluable patients receiving doublet regimens. Multivariate analysis revealed that poor Eastern Cooperative Oncology Group performance status (≥2), poorly differentiated histology, and duodenal tumor location independently predicted worse OS. Palliative chemotherapy significantly prolongs survival in patients with advanced SBA compared with that of BSC, particularly in those with a good performance status. Doublet fluoropyrimidine-based regimens offered superior outcomes. These findings support the use of systemic chemotherapy for this rare malignancy, highlighting the significance of patient selection and performance status in guiding treatment decisions.

Background: Cancer epidemiology data for people living with human immunodeficiency virus (PLWH) in Thailand, particularly in the era of combination antiretroviral therapy (ART), remain limited. In this study, we describe the prevalence, temporal trends, clinical characteristics, and survival outcomes of patients with AIDS-defining cancers (ADCs) and non-AIDS-defining cancers (NADCs). Methods: We retrospectively reviewed adult PLWH diagnosed with malignancy at Songklanagarind Hospital in Thailand during 2003–2023. Demographic, human immunodeficiency virus (HIV)-related, and clinical data were analyzed using chi-square and Wilcoxon rank-sum tests and the Kaplan–Meier method. Results: Among 444 patients, 231 had NADCs and 213 had ADCs. The NADC proportion increased markedly over time. Common ADCs included non-Hodgkin lymphoma and cervical cancer; common NADCs included lung cancer, non-nasopharyngeal head and neck cancer, and hepatocellular carcinoma. Compared with patients with ADCs, those with NADCs were older, more often male, and had higher proportions of undetectable HIV viral load, CD4 counts ≥200 cells/µL, and ART use. Approximately one-third of patients presented with advanced-stage disease, and the median overall survival was 15.9 months. Conclusions: Over two decades, NADCs have become the predominant malignancy in Thai PLWH, associated with older age, male sex, and improved immune function. This reflects the evolving cancer risk in the era of combination ART. We suggest employing multidisciplinary approaches involving HIV and cancer care to improve survival outcomes and integrating age-appropriate screening for common NADCs into HIV care.

Background: Small-bowel cancers (SBCs) are rare, histologically diverse malignancies with limited data from Asian populations. This study aimed to describe histological subtype distribution, clinical features, survival outcomes, and prognostic factors in SBCs over a 20-year period. Methods: We retrospectively reviewed patients diagnosed with SBC at a tertiary referral center in Southern Thailand (2005–2024). Clinical, pathological, and radiological data were analyzed by histologic subtype. Results: A total of 158 patients were included: adenocarcinoma (81.0%), gastrointestinal stromal tumor (GIST, 5.7%), well-differentiated neuroendocrine tumor (NET, 5.7%), other sarcomas (5.1%), and poorly differentiated neuroendocrine carcinoma (NEC, 2.5%). Adenocarcinoma predominantly affected older patients and frequently presented with advanced-stage disease and poor performance status, whereas NET and NEC occurred in younger patients typically at early NET and metastatic NEC stages. Median overall survival (OS) varied by subtype: adenocarcinoma (8.3 months), GIST (63.6 months), NEC (8.9 months), NET (not reached), and other sarcomas (9.8 months). Five-year OS rates were 14.0%, 55.6%, 0%, 88.9%, and 18.8%, respectively. Eastern Cooperative Oncology Group performance status ≥2, duodenal location, and metastatic disease were independently associated with worse OS. Conclusions: SBCs display distinct clinical and prognostic profiles by subtype. Overall prognosis remained poor, underscoring the need for earlier detection and subtype-specific management.

Background: Small bowel adenocarcinoma (SBA) is a rare malignancy, and the role of adjuvant chemotherapy following curative resection remains unclear owing to limited supporting evidence. In this study, we aimed to evaluate the real-world effectiveness of adjuvant chemotherapy in patients with resected SBA. Methods: We retrospectively reviewed data from patients with localized SBA who underwent curative resection at a single tertiary referral center in Southern Thailand between 2005 and 2024. Results: Of 128 patients diagnosed with SBA, 52 (40.6%) had localized disease and underwent curative resection. Among them, 29 patients (55.8%) received adjuvant chemotherapy and 23 (44.2%) were managed with observation alone. The median disease-free survival (DFS) was 18.1 and 16.2 months in the adjuvant chemotherapy and observation groups, respectively (p = 0.642). The median overall survival (OS) was 42.8 vs. 26.7 months, respectively (p = 0.179). Subgroup analyses revealed trends favoring adjuvant chemotherapy in patients with pathological T4 disease, nodal involvement, younger age, and non-underweight body mass indices. Positive surgical margins were associated with inferior DFS, and T4 stage was associated with worse OS. Disease recurrence occurred in 59% of patients, predominantly as distant metastasis. Conclusions: Adjuvant chemotherapy showed a trend toward improved survival, particularly in patients with high-risk features; however, these findings should be interpreted with caution given the limited sample size and retrospective design. These results highlight the importance of individualized treatment decisions and underscore the need for larger multi-institutional studies to clarify the role of adjuvant chemotherapy and identify prognostic biomarkers for this rare malignancy.

Ampullary adenocarcinoma is a rare malignancy with limited evidence on the efficacy of systemic chemotherapy for advanced disease. This study aimed to evaluate the treatment outcomes of gemcitabine- and fluoropyrimidine-based regimens and the benefits of platinum combination therapy. This retrospective study reviewed the data of patients with advanced ampullary adenocarcinoma treated at a university hospital in Southern Thailand between 2005 and 2024. Among the 97 patients, 71 (73.2%) received palliative chemotherapy, including 43 (60.6%) receiving gemcitabine-based regimens and 28 (39.4%) receiving fluoropyrimidine-based regimens. Median overall survival (OS) and progression-free survival (PFS) for gemcitabine-based vs. fluoropyrimidine-based regimens were 14.4 vs. 11.5 months (adjusted hazard ratio [HR] 0.85; 95% CI 0.34-2.13; P = 0.725) and 8.67 vs. 7.18 months (adjusted HR 0.60; 95% CI 0.26-1.36; P = 0.219), respectively. No significant difference in OS or PFS was observed between platinum combination and single-agent chemotherapy. The objective response rate (ORR) was 9.3% for gemcitabine-based therapy, 14.3% for fluoropyrimidine-based therapy, and 26.9% for platinum combination therapy, compared to 2.2% for monotherapy. Gemcitabine- and fluoropyrimidine-based regimens demonstrated comparable survival outcomes. Platinum-combination chemotherapy was associated with a higher ORR, but no significant OS or PFS benefit was observed. Therefore, platinum-combination regimens may be considered in selected patients requiring tumor shrinkage, and these findings should be interpreted as hypothesis-generating real-world evidence.