Phase II Trial of FOLFIRINOX in Advanced Biliary Tract Cancer.

INTRODUCTION: Biliary tract cancers (BTCs), characterized by poor prognosis and limited treatment options, are increasingly prevalent malignancies with a five-year survival rate of less than 20% for advanced-stage disease. The standard first-line chemotherapy combining gemcitabine and cisplatin offers modest survival benefits, necessitating the exploration of more effective therapies. This study reports the results of a single-arm, open-label, phase 2 trial assessing the efficacy and safety of fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFIRINOX) as a first-line treatment for metastatic or locally advanced unresectable BTC. METHODS: Patients aged ≥18 with measurable disease and adequate organ function were enrolled, receiving biweekly FOLFIRINOX for up to 12 cycles with follow-up imaging every four cycles. The primary endpoint was the overall response rate (ORR), with progression-free survival (PFS), overall survival (OS), and safety as secondary endpoints. RESULTS: Thirteen patients were enrolled from December 2016 to September 2021 before early termination due to slow accrual and the emergence of immunotherapy. The ORR was 54%, with a disease control rate of 77%. Median PFS and OS were 6.8 and 19.25 months, respectively. Grade 3/4 toxicities were predominantly hematologic, with neutropenia being the most common severe adverse event. CONCLUSION: The trial suggests that FOLFIRINOX is a potentially effective first-line therapy for unresectable or metastatic BTC with a manageable safety profile. However, the early termination of the study and the introduction of immunotherapy warrant further research to confirm these findings.

Characteristics and outcomes of small bowel adenocarcinoma: 14 years of experience at a single tertiary hospital in Saudi Arabia.

Small bowel adenocarcinoma (SBA) is an extremely rare cancer type. In the present study, the patient characteristics and clinical outcomes of patients diagnosed and treated for SBA at a single tertiary hospital were reported. All patients diagnosed and managed between 2007 and 2020 were reviewed. Regression analysis was used to assess variables associated with the metastatic stage at diagnosis. The Kaplan-Meier method was used to estimate survival and the log-rank test was used to determine factors associated with survival outcomes. Out of 137 cases of small bowel primary tumor, 43 consecutive patients with SBA were diagnosed with a median age of 53 years and the majority (76.7%) were males. The common initial presenting symptoms were abdominal pain (58.8%) and bowel obstruction (30.2%). The most common primary site was the duodenum (60.5%) and the majority (65.1%) were diagnosed with stage III/IV disease. Patients with a high neutrophil-lymphocyte ratio (NLR) (≥0.85) were more likely to be in the metastatic stage at diagnosis (P=0.01). The 3-year overall survival (OS) rates based on stage were 100% (I), 85% (II), 53% (III) and 33.9% (IV) (P=0.001). In addition to the stage, the Eastern Cooperative Oncology Group Performance Status (P<0.001), NLR (P<0.001), hypoalbuminemia (P=0.02) and chemotherapy in a metastatic setting (P=0.02) were prognostic factors for OS. In conclusion, NLR is a potential prognostic biomarker for a metastatic stage at diagnosis. Advanced stage, lower performance status score, low albumin level and high NLR are associated with short OS.

Outcomes and Prognostic Factors of Metastatic Gastric Cancer: A Single-Center Experience.

Background Gastric cancer (GC) carries a poor survival outcome despite the availability of many therapeutic agents active in treatment. In this study, we aimed to evaluate the survival outcomes of metastatic GC treatment from a single center in Saudi Arabia and identify possible prognostic factors. Methodology Data on patients diagnosed with metastatic GC between December 2009 and November 2013 were collected and analyzed. Results During this period, 41 patients were diagnosed with a median age at diagnosis of 52 years, and 56.1% of patients were males. Only four (9.2%) patients had human epidermal growth factor receptor 2 overexpression. Overall, 83% were treated with oxaliplatin-based chemotherapy. The median progression-free survival (PFS) and overall survival (OS) were 4.1 and 15.4 months, respectively. Female sex was an independent prognostic factor for better PFS and OS. Normal lymphocyte count was associated with improved PFS. Conclusions Our study highlights poor outcomes in patients with metastatic GC and the need for further research in this field.

Prognostic significance of peritoneal metastasis from colorectal cancer treated with first-line triplet chemotherapy.

BACKGROUND: Peritoneal metastasis from colorectal cancer (CRC) carries a poor prognosis in most studies. The majority of those studies used either a single-agent or doublet chemotherapy regimen in the first-line setting. AIM: To investigate the prognostic significance of peritoneal metastasis in a cohort of patients treated with triplet chemotherapy in the first-line setting. METHODS: We retrospectively evaluated progression-free survival (PFS) and overall survival (OS) in 51 patients with metastatic CRC treated in a prospective clinical trial with capecitabine, oxaliplatin, irinotecan, and bevacizumab in the first-line setting according to the presence and absence of peritoneal metastasis. Furthermore, univariate and multivariate analyses for PFS and OS were performed to assess the prognostic significance of peritoneal metastasis at the multivariate level. RESULTS: Fifty-one patients were treated with the above triplet therapy. Fifteen had peritoneal metastasis. The patient characteristics of both groups showed a significant difference in the sidedness of the primary tumor (left-sided primary tumor in 60% of the peritoneal group vs 86% in the nonperitoneal group, P = 0.03) and the presence of liver metastasis (40% for the peritoneal group vs 75% for the nonperitoneal group, P = 0.01). Univariate analysis for PFS showed a statistically significant difference for age less than 65 years (P = 0.034), presence of liver metastasis (P = 0.046), lung metastasis (P = 0.011), and those who underwent metastasectomy (P = 0.001). Only liver metastasis and metastasectomy were statistically significant for OS, with P values of 0.001 and 0.002, respectively. Multivariate analysis showed that age (less than 65 years) and metastasectomy were statistically significant for PFS, with P values of 0.002 and 0.001, respectively. On the other hand, the absence of liver metastasis and metastasectomy were statistically significant for OS, with P values of 0.003 and 0.005, respectively. CONCLUSION: Peritoneal metastasis in patients with metastatic CRC treated with first-line triple chemotherapy does not carry prognostic significance at univariate and multivariate levels. Confirmatory larger studies are warranted.

Recurrence and progression in nonmuscle invasive transitional cell carcinoma of urinary bladder treated with intravesical Bacillus Calmette-Guerin: A single center experience and analysis of prognostic factors.

BACKGROUND: Intravesical Bacillus Calmette-Guerin (BCG) has been the standard of care for the prevention of nonmuscle invasive bladder cancer (NMIBC) recurrence following resection. Attempts to improve on the result by combining it with other agents have largely failed. This study addresses the result of BCG therapy in our patient population and compares the result with our combination BCG and interferon therapy published earlier. MATERIALS AND METHODS: The medical records of patients diagnosed with NMIBC and treated with transurethral resection and intravesical BCG were reviewed. Univariate analysis was performed on most known prognostic factors. Results were compared to published data on the use of BCG and interferon from the same institution. RESULTS: Thirty-one patients were identified. Median age was 66 (range 33-109), 80.6% were males. Fourteen patients (45%) had ≤ 3 tumors and 18 (58.1%) had T1 lesions. Four patients (12.9%) had Grade 3 tumors and 25 (80.6%) had Grade 2 tumors. One patient (3.2) had concurrent carcinoma in situ and 11 (35.5%) were treated upon initial diagnosis. At 5 years, the relapse-free survival was 61.3% (95% confidence interval (CI) 44.2-78.4%), progression-free survival was 85.6% (95% CI 73.3-97.9%), and overall survival was 93% (95% CI 84.1-100%). Comparison with the BCG and interferon data showed no significant difference. CONCLUSION: The result of BCG therapy in our patient population is similar to western reported data. Efficacy of BCG alone is equal to BCG and interferon within our institution.

The attitude towards disclosure of bad news to cancer patients in Saudi Arabia.

Disclosing the diagnosis or prognosis to cancer patients in Saudi Arabia can be a serious challenge to the physician in his daily clinic practice. The public attitude towards full disclosure is still conservative, and in order to appropriately deal with such an attitude, physicians need to deeply understand its sociocultural background. This article attempts to look into what governs the public attitude towards disclosure in Saudi Arabia as an example of what may affect attitudes in developing countries. It also brings some data from local surveys among physicians and patients as well as from public surveys to describe the changing trend in attitude over the years with a comparative analysis of the Western literature.