Adjuvant chemotherapy in 780 patients with early breast cancer: 10-year data from Saudi Arabia.

BACKGROUND: By and large, data about adjuvant chemotherapy for breast cancer in the Middle East are lacking. Retrospective analysis of prospectively captured data from a main referral center in the Kingdom of Saudi Arabia (KSA) may shed some light on the clinicopathological features and survival of patients offered adjuvant chemotherapy in a similar population in that part of the world. PATIENTS AND METHODS: Data on patients with invasive breast cancer (Stages I to IIIA) seen between 1992 and the end of 2001 and who received adjuvant chemotherapy were analyzed. A total of 780 patients were considered eligible and constitute the basis of this report. RESULTS: The median age +/- SD of the 780 patients was 42 +/- 9.6 yr. The majority of patients were younger than 50 yr (78%) and premenopausal (83%). Ten percent, 69%, and 21% of patients had Stage I, II, and IIIA, respectively. Patients expressed relatively high prevalence of adverse clinicopathological characteristics. Most patients (523 patients, 67%) received anthracyclines-containing adjuvant chemotherapy, 610 patients (78%) received adjuvant radiotherapy, and 296 (38%) received adjuvant tamoxifen. At a median follow-up of 42 mo (95% CI, 38.1-62.8 mo), the median overall (OS) and disease-free survival (DFS) were not reached; however, the 5-yr actuarial survival was estimated as 74% and 59%, respectively. Cox proportional regression hazard model identified positive axillary nodal status, and positive vascular invasion are the only variables that influenced OS adversely. The model also distinguished the same variables plus negative estrogen receptor status as covariates with negative effect on DFS. CONCLUSION: In conclusion, this series of 780 predominantly young patients with breast cancer receiving adjuvant chemotherapy highlighted the disease patterns and survival outcome in the KSA. The current series is significant being one of the few reports about adjuvant chemotherapy experience in a developing country and certainly the first from that part of the world.

A pilot trial of combination cisplatin, 5-fluorouracil and interferon-alpha in the treatment of advanced esophageal carcinoma.

BACKGROUND/OBJECTIVES: Based on the synergistic effect between cisplatin and 5-fluorouracil (5-FU), and between 5-FU and interferon-alpha, we conducted a trial to assess the response rate and toxicity of the combination of cisplatin, 5-FU and interferon-alpha in patients with advanced esophageal cancer. METHODS: Patients with locally advanced or metastatic squamous cell or adenocarcinoma of the esophagus were eligible. No prior chemotherapy or interferon were allowed. Patients received cisplatin 80 mg/m(2) on day 1, 5-FU 750 mg/m(2)/day by continuous intravenous infusion for 5 days, and interferon-alpha 5 x 10(6) units/m(2)/day by subcutaneous injection on days 1-5 of each cycle. Cycles were repeated every 21 days for a total of 6 cycles. RESULTS: Forty patients were enrolled. Median age was 57.5 years (range 30-70). 33 had squamous carcinoma and 7 adenocarcinoma; 15 were male; the locoregional metastatic ratio was 1:39; median ECOG performance status was 2 (range 1-3). Grade 3-4 toxicities were: leukopenia (9 cases), thrombocytopenia (4), electrolyte imbalance (11), febrile neutropenia (11), vomiting (5), diarrhea (4), and mucositis (11). There were 3 early deaths, most probably related to therapy. Five patients (13%) achieved a complete response and 17 (42%) achieved a partial response, yielding an overall response rate of 55%. Response rates for squamous and adeno histology were 61% and 29%, respectively. Median survival was 6.4 months. CONCLUSION: The combination of cisplatin, 5-FU and interferon-alpha produces a high response rate in advanced squamous cell esophageal carcinoma, but with considerable toxicity. A modified combination of the above agents is presently being evaluated at our institution.

HER-2/Neu overexpression does not predict response to neoadjuvant chemotherapy or prognosticate survival in patients with locally advanced breast cancer.

Data about the prognostic and predictive value of HER-2/neu overexpression in patients with locally advanced breast cancer (LABC) treated with primary chemotherapy is limited. Therefore, this retrospective study was performed to examine this issue. Fifty-four consecutive patients with LABC were prospectively managed using a uniform multimodality approach. Response to neoadjuvant chemotherapy and survival were examined against HER-2/neu overexpression as determined by an immunohistochemistry method on formalin-fixed, paraffin-embedded samples of breast cancer using the commercially available, United States Food and Drug Administration-approved kit HercepTest (Dako Corp, Carpinteria, CA). The number of patients in each HercepTest immunostaining group were as follows; 0 in 12 patients (22%), 1+ in 8 (15%), 2+ in 12 (22%), and 3+ in 22 (41%). None of the clinical variables was significantly associated with HER-2/neu expression. After primary therapy, 22% of patients attained clinical complete response and an additional 70% achieved clinical partial response with an overall response rate of 92% (95% confidence interval: 100% to 79%). There was no significant correlation between clinical response and HercepTest positivity (p = 0.85). Of 52 patients with complete pathological data, there was no significant difference in HercepTest status between those who attained complete pathological response (46%) and those who did not (38%) (p = 0.74). Moreover, there was no significant difference in disease-free survival (75% vs 84%, [p = 0.26]) or overall survival (81% vs 84% [p = 0.31]) between those who overexpressed HER-2/neu and those with negative HercepTest, respectively. In patients with LABC, HER-2/neu overexpression determined using HercepTest assay and according to the manufacturer's approved guidelines failed to demonstrate a predictive or a prognostic role.