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Abstract Background Maintenance therapy for non-small cell lung cancer (NSCLC) aims to extend disease control after first-line chemotherapy with active and well-tolerated agents. The utility of continuation maintenance therapy requires further research. Methods This multicenter, randomized, phase 2 study compared continuation maintenance therapy with pemetrexed (500 mg/m2 every 21 days) and best supportive care (BSC) versus BSC alone in patients with advanced, non-squamous NSCLC who had not progressed after 4 cycles of induction chemotherapy with pemetrexed (500 mg/m2) and cisplatin (75 mg/m2). The primary endpoint was progression-free survival (PFS) from randomization, was analyzed using a Cox model, stratified for the tumor response at the end of induction therapy, at a one-sided alpha of 0.2. Secondary endpoints: response and disease control rates, overall survival (OS), one year survival rates, and treatment-emergent adverse events (TEAEs). Results A total of 106 patients commenced induction therapy, of whom 55 patients were randomized to maintenance pemetrexed/BSC (n = 28) or BSC (n = 27). Although the median PFS time for maintenance phase for both arms was 3.2 months, the one-sided p-value for the PFS HR comparison was less than the prespecified limit of 0.2 (HR = 0.76, two-sided 95% confidence interval [CI]: 0.42 to 1.37; one-sided p-value = 0.1815), indicating that PFS was sufficiently long in the pemetrexed/BSC arm to warrant further investigation. Similar PFS results were observed for the overall study period (induction plus maintenance) and when the PFS analysis was adjusted for sex, baseline disease stage, and the ECOG PS prior to randomization. The median OS for the maintenance phase was 12.2 months (95%CI: 5.6 to 20.6) for the pemetrexed/BSC arm and 11.8 months (95% CI: 6.3 to 25.6) for BSC arm. The one-year survival probabilities were similar for both arms for the maintenance phase and the overall study period. Both the induction and continuation maintenance therapies were generally well-tolerated, and similar proportion of patients in each arm experienced at least 1 grade 3/4 TEAE (pemetrexed/BSC, 17.9%; BSC, 18.5%). Conclusions Continuation pemetrexed maintenance therapy resulted in promising PFS with an acceptable safety profile in a Middle Eastern population with advanced non-squamous NSCLC and is worthy of further investigation. Trial registration NCT00606021

Background: Oxaliplatin-based regimens (XELOX, FOLFOX4, and FOLFOX6) have substantially improved the response of patients with colorectal cancer. The objective of this study is to investigate the "real life" use of Oxaliplatin-based regimens in treating patients whether adjuvant, neoadjuvant or palliative for metastatic colorectal cancer and figure out the safety profile of these regimens. Subjects and Methods: In this observational, multi-centre, prospective study, the selection of the Oxaliplatin-based regimens was left to the investigator's clinical practice to reflect the "in practice" approach. Data were recorded at different time-points; at the inclusion visit, during each treatment administration and end of treatment. Safety outcomes were measured throughout treatment. Results: Of the 41 patients recruited for the study, two patients were excluded because the date of the informed consent was before the study protocol date. All remaining patients (n= 39) were included in the safety analysis. Only 19 patients were included in the efficacy analysis; distributed as the following; 10 (52.6%) XELOX, 5 (26.3%) FOLFOX6, and 4 (21.1%) FOLFOX4. Out of them, 9 (47.4%) patients showed response to treatment, whether partial 8 (42.1%) or complete 1 (5.3%), stable in 1 (5.3%) patients, and progressive in 9 (47.4%) patients. The overall response distributed as following; 2/10 (20%) for XELOX, 4/5 (80%) for FOLFOX6, and 3/4 (75%) for FOLFOX4. Fatigue was the most commonly reported adverse events by two events, followed by diarrhea, vomiting and anemia, one event each. Conclusion: The prescription of Oxaliplatin-based regimens in treating patients with colorectal cancer in Egypt was an efficient incomplete/partial tumor response. The reported adverse events and serious adverse events consisted of the known safety profile of Oxaliplatin. [ABSTRACT FROM AUTHOR]

Objective: To evaluate elective neck treatment in patients with early stage (T1-2 negative neck node [N0]) squamous cell carcinoma of the oral tongue., Methods: The medical records of all patients with early stage (T1-2 N0) of oral tongue cancer at the King Faisal Specialist Hospital and Research Center, Riyadh, Kingdom of Saudi Arabia, between January 1980 and December 1997, were identified and retrospectively reviewed., Results: Our cohort consisted of 93 patients: 45 males and 48 females, with a median age of 60 years. All patients received treatment with curative intent. Partial glossectomy was carried out, except for 8 patients who underwent tongue brachytherapy. The neck was observed in 29 patients, 36 were treated by modified neck dissection, and 28 by elective neck irradiation. With a median follow-up of 62 months, 29 patients had documented neck node recurrence. Ninety six percent (28/29) of recurrences occurred within 22 months from treatment completion. The 5 year actuarial event free survival with regard to nodal relapse in observed was 59%, dissected was 79% and irradiated neck was 63%. Our results showed a trend toward better neck node control in patients managed by elective neck dissection compared to those observed (p=0.07) or receiving elective neck irradiation (p=0.18). Tumor thickness of more than 10 mm was associated with increased risk of nodal relapse (p=0.0004). Neck node recurrence has a poor prognosis with a 5 year disease specific survival of 16%., Conclusion: A trend for higher neck control was observed after neck dissection in patients with T1-2 N0 squamous cell carcinoma of the oral tongue. Elective neck dissection should be considered particularly for patients with tumor thickness of more than 10 mm.

Objective: To evaluate the outcome of radical treatment for patients with stage IV squamous cell carcinoma of the oral cavity., Methods: Using head and neck tumor database, 57 patients with stage IV non-metastatic invasive squamous cell carcinoma of the oral cavity treated with curative intent at King Faisal Specialist Hospital and Research Center, Riyadh, Kingdom of Saudi Arabia, between July 1992 and June 1998, were identified and retrospectively reviewed., Results: Our cohort of patients consisted of 33 males and 24 females, with a median age of 65 years. The primary sites were alveolus (26), tongue (22), buccal mucosa (6), floor of mouth (2) and retromolar trigone (one). Definitive radiotherapy was used in 7 patients, surgery in 17 and combined modality in 33. With a median follow-up for surviving patients of 53-months, the actuarial 5-year overall survival and relapse free survival was 20% and 14%. Tumors arising from the alveolus showed a better outcome as compared to the rest of oral cavity sites with an overall survival and relapse free survival of 32% and 26% compared to 8% and 4% (p value=0.0057 and 0.0038)., Conclusion: Advanced oral cavity tumors are aggressive neoplasms with a poor outcome to conventional treatment modalities. New approaches like neoadjuvant or concurrent chemoradiotherapy with or without surgery need to be considered and evaluated in prospective studies.

The purpose of this report is to assess the prognostic factors that could influence management and clinical outcome of malignant fibrous histiocytoma (MFH) of soft tissues. Between 1975 and 1998, 109 patients diagnosed with MFH of the soft tissues, seen at King Faisal Specialist Hospital and Research Center, have been reviewed. Of the 109 patients, 75 were men and 34 were women. The median age at presentation was 48 years (range: 3-94). Seven patients (6%) had regional nodal disease and 10 other patients (9%) with distant metastases were excluded from survival analysis. The remaining 92 patients had localized disease and had surgery as the primary treatment modality with or without radiotherapy and/or chemotherapy. Extremities were the most common location (58%). Tumors less than 5 cm represented 32%, whereas 68% had tumors 5 cm or more. Low-grade tumors constituted 46%, and the remaining 54% were high grade. Thirty-seven percent of patients had positive surgical margins histologically after complete gross resection. The 5- and 10-year relapse-free survival (RFS) rates were 39% and 36%, respectively. Isolated local recurrence occurred in 20 patients (22%), isolated metastatic disease without local recurrence in 9 patients (10%), and combined local and metastatic disease occurred in 20 patients (22%). The overall 5- and 10-year overall survival (OS) rates were 50% and 43%, respectively. On multivariate analysis, tumor size and radiation dose were significant factors for RFS (p = 0.04 and 0.0005, respectively). In terms of OS, size, histologic grade, and surgical margins were significant factors on multivariate analysis (p = 0.001. 0.006, and 0.0001, respectively). Complete surgical resection at the time of primary tumor presentation is likely to afford the best chance for RFS and OS. Radiation therapy plays an important role, in combination with surgery for better local control, particularly in high-grade lesions, and in cases with positive surgical margins after wide complete gross excision. The role of adjuvant chemotherapy remains investigational.