Pulmonary metastatectomy in pediatric cancer patients at National Cancer Institute, Egypt: prognostic factors and outcome.

BACKGROUND: Metastatic tumors account for 80% of all lung tumors in children. Wilms tumour and osteosarcoma are the most tumors of childhood that produce lung metastases. The aim of the current study is to assess the prognostic factors of pulmonary metastatectomy in pediatric solid tumours as age, number, size, site,laterality, resectability of pulmonary nodules, and number of Thoracotomies. Calculate overall survival among patients who underwent pulmonary metastatectomy. METHODS: It is a retrospective study including all pediatric patients with metastatic solid tumors to lungs treated at pediatric oncology department, National Cancer Institute, Cairo University from 2008 to 2014. Fifty-five patients were included, 43 (78.2℅) patients of them had Osteosarcoma. RESULTS: Thirty (54.5℅)patients were male. The mean age was 15 years ranging from (4.5- 23) years. The site of primary disease was at lower limbs in 43 (78.2%) patients. All patients underwent complete surgical resection of the primary disease with negative margin, 22(51.1%) of the osteosarcoma patients did amputation with tumor necrosis less than 90%. All patients received chemotherapy and only 9 received radiation therapy. The patients were classified into four groups according to time of diagnosis of pulmonary metastasis: at time of diagnosis in 13 (21.8%) patients, within treatment in 16 (30.9%) patients, within first year follow up in 18 (32.7%) patients and detected late in 8 (14.5%) patients. Bilateral lung metastasis diagnosed by CT chest were detected in 42 (76.4%) patients. Size of metastatic nodules was ranging from (0.5 to 10 cm) with mean 3.4 cm. Number of metastatic nodules was ranging from (1 to 28) median 4.Metastatic complications were detected in 19 patients. 5-year OS was 74.8% in the study group, and 68% in osteosarcoma patients. Effect of prognostic factors as sex, time of respectability, laterality, tumor necrosis of the 1ry disease, Timing of lung metastasis, size and site of the primary, Surgical approach of metastatectomy, postoperative complications on overall survival of the studied patients was done with significant P-value of tumor necrosis of the 1ry disease and Timing of lung metastasis 0.017, 0.001 respectively. CONCLUSION: Resection of pulmonary metastases of pediatric solid tumours is a safe and effective treatment that offers better survival.

Health-Related Quality of Life among Egyptian Female Breast Cancer Patients at the National Cancer Institute, Cairo University.

BACKGROUND: To measure the quality of life (QoL) of Egyptian females with breast cancer (BC) at the National Cancer Institute (NCI), Cairo University (CU) and its relations with the socio-demographic and clinical characteristics. METHODS: A total of 200 female BC patients were recruited from the medical oncology outpatient clinic during a period from December 2015 to March 2018. The instrument of this study consisted of two parts: the first for Socio-demographic and clinicopathological characteristics, and the second was the Functional Assessment of Cancer Therapy-Breast for patients with Lymphedema (FACT-B+4) questionnaire. RESULTS: The majority of the study participants were married, housewives, and without a family history of cancer (70.0%, 93.0%, and 63.0%, respectively). Most of them presented with breast mass, had IDC, grade II and disease stage III at diagnosis (89.0%, 84.5%, 85.6% and 56.8%, respectively) and had undergone modified radical mastectomy, received adjuvant chemotherapy, radiation, and hormonal therapy (62.0%, 83.8%, 73.5% and 60.5%, respectively). The median FACT-B score was 81 (range 35-133). The medians of subscales were: physical well-being 13 (range 0-28), social well-being 20 (range 0-28), emotional well-being 15 (range 2-24), and functional well-being 16 (range 2-28). The median score for breast subscale was 19 (range 2-32). Many factors affected the QoL scores, including age, marital status, occupation, smoking, residence, comorbidities, symptoms, grade, chemotherapy, radiation, and recurrence. CONCLUSION: QoL of Egyptian females with BC was influenced by several factors like age, marital status, occupation, smoking, residence, comorbidities, symptoms, grade, chemotherapy, radiation, and recurrence.

Robotic-Assisted versus Conventional Laparoscopic Approach for Rectal Cancer Surgery, First Egyptian Academic Center Experience, RCT.

BACKGROUND: Undoubtedly, robotic systems have largely penetrated the surgical field. For any new operative approach to become an accepted alternative to conventional methods, it must be proved safe and result in comparable outcomes. The purpose of this study is to compare the short-term operative as well as oncologic outcomes of robotic-assisted and laparoscopic rectal cancer resections. METHODS: This is a prospective randomized clinical trial conducted on patients with rectal cancer undergoing either robotic-assisted or laparoscopic surgery from April 2015 till February 2017. Patients' demographics, operative parameters, and short-term clinical and oncological outcomes were analyzed. RESULTS: Fifty-seven patients underwent permuted block randomization. Of these patients, 28 were assigned to undergo robotic-assisted rectal surgery and 29 to laparoscopic rectal surgery. After exclusion of 12 patients following randomization, 45 patients were included in the analysis. No significant differences exist between both groups in terms of age, gender, BMI, ASA score, clinical stage, and rate of receiving upfront chemoradiation. Estimated blood loss was evidently lower in the robotic than in the laparoscopic group (median: 200 versus 325 ml, p= 0.050). A significantly more distal margin is achieved in the robotic than in the laparoscopic group (median: 2.8 versus 1.8, p< 0.001). Although the circumferential radial margin (CRM) was complete in 18 patients (85.7%) in the robotic group in contrast to 15 patients (62.5%) in the laparoscopic group, it did not differ statistically (p=0.079). The overall postoperative complication rates were similar between the two groups. CONCLUSION: To our knowledge, this is the first prospective randomized trial of robotic rectal surgery in the Middle East and Northern Africa region. Our early experience indicates that robotic rectal surgery is a feasible and safe procedure. It is not inferior to standard laparoscopy in terms of oncologic radicality and surgical complications. Organization number is IORG0003381. IRB number is IRB00004025.

Large Bariatric-Specific Stents and Over-the-Scope Clips in the Management of Post-Bariatric Surgery Leaks.

BACKGROUND: Endoscopic stents are successful in the management of surgical leaks; however, stent migration remains a significant problem. In this study, we present our approach depending on a large bariatrics-specific stent (Mega stent) and over-the-scope clips in the management of post-bariatric surgery leaks. METHODS: A retrospective analysis of all patients with post-bariatric surgery leaks treated at our institution using an approach reliant on Mega stents and over-the-scope clips was conducted. Potential factors associated with procedure success and occurrence of complications were also evaluated. RESULTS: A total of 81 stents were inserted in 62 patients with post-bariatric surgery leaks, 46 sleeve gastrectomies (73%) and 16 Roux-en-Y gastric bypass (27%). Over-the-scope clips were applied in 29 patients (46%). Leak closure was achieved in 51 patients (82%). Median number of procedures per patient was 3 (range 2-8). Complications included the following: stent migration (11/62, 18%), intolerance necessitating premature removal (7/62, 11%), esophageal stricture (8/62, 13%), bleeding (4/62, 6%), perforation (4/62, 6%). One stent-induced mortality was encountered (bleeding). The presence of open surgery (vs laparoscopic) was significantly associated with the occurrence of stent-induced complications (p 0.002). CONCLUSION: The approach combining Mega stents and over-the-scope clips is highly effective in the management of post-bariatric surgery leaks and is associated with a low rate of stent migration and a low number of procedures and stents per patient. Mega stents, however, should be used with great caution due to the significant morbidity associated with their use.

Diagnostic Criteria in Intraepithelial Pagetoid Neoplasms: A Histopathologic Study and Evaluation of Select Features in Paget Disease, Bowen Disease, and Melanoma In Situ.

BACKGROUND: Paget disease, Bowen disease, and malignant melanoma in situ are intraepidermal neoplasms, characterized by the presence of pagetoid scatter of atypical cells in the epidermis. This study reviewed the frequency of select histologic criteria to validate their usefulness in the histologic distinction between these entities. METHODS: One hundred forty-four specimens with the diagnosis of Bowen disease, 144 specimens with Paget disease (mammary and extramammary), and 144 specimens with malignant melanoma in situ were examined microscopically to define frequencies of select histologic criteria present in each disease. RESULTS: Comparison between mammary Paget and extramammary Paget disease showed no significant differences in the features studied. Crushing of basal keratinocytes, presence of atypical cells in the corneum, and presence of large cells with amphophilic cytoplasm were significantly noted in Paget disease. Transition between the atypical clear cells and surrounding keratinocytes was absent in all cases of melanoma in situ and in 87 (60.4%) cases of Paget disease, but it was significantly associated with Bowen disease (98.6%). Dyskeratotic cells were significantly associated with Bowen disease cases. CONCLUSION: Our study demonstrated a practical histologic approach to differentiate between intraepidermal pagetoid neoplasms. Careful histologic study of the proposed criteria may reduce reliance on immunohistochemical stains.

Portal Vein Thrombosis in Unresectable Hcc Cases: a Single Center Study of Prognostic Factors and Management in 140 Patients

Objective: Hepatocellular carcinoma with portal vein thrombosis is considered a relative contraindication for transarterial chemoembolization (TACE). The aim of our study was to evaluate the prognostic factors and management in patients with hepatocellular carcinoma with portal vein thrombosis (PVT). Methods: Between February 2011 and February 2015, 140 patients presented to our specialized multidisciplinary HCC clinic. All were assessed by imaging at regular intervals for tumor response and the data compared with baseline laboratory and imaging characteristics obtained before treatment. Results: At the end of the follow up in February 2015, 78 (55.7%) of the 140 patients had died, 33.1% in the 1st year and 20.7% in the 2nd year. The overall median survival was 10 months from the date of diagnosis. Clinical progression was noted in 45 (32.1%). Univariate analysis revealed that, the Child-Pugh score, the performance states (Eastern Cooperative Oncology Group "ECOG" 0-1) and the presence of ascites exerted non-significant affects on survival. Similarly, the serum albumen level and AFP >400 ng/ml were without influence. However, patients with =>2 tumors, abdominal lymphadenopathy and serum bilirubin >2mg/dl had a significantly worse prognosis. Specific treatment significantly increased survival compared to patients left untreated (P value = 0.027). Conclusion: Application of specific treatments (curative or palliative) significantly increased survival in HCC patients with PVT. TACE can be considered as a promising procedure for unresectable PVT-associated HCCs. The main predictors of survival in our study were the serum bilirubin level and specific treatment application.

Assessment of Statistical Methodologies and Pitfalls of Dissertations Carried Out at National Cancer Institute, Cairo University

Purpose: To identify statistical errors and pitfalls in dissertations performed as part of the requirements for the Medical Doctorate (MD) degree at the National Cancer Institute (NCI), Cairo University (CU) to improve the quality of medical research. Methods: A critical assessment of 62 MD dissertations conducted in 3 departments at NCI, CU, between 2009 and 2013 was carried out regarding statistical methodology and presentation of the results. To detect differences in study characteristics over time, grouping was into two periods; 2009-2010 and 2011-2013. Results: Statistical methods were appropriate in only 13 studies (24.5%). The most common statistical tests applied were chi-square, log-rank, and Mann-Whitney tests. Four studies estimated sample size and/or power. Only 37.1% and 38.7% of dissertation results supported aims and answered the research questions, respectively. Most of results were misinterpreted (82.3%) with misuse of statistical terminology (77.4%). Tabular and graphical data display was independently informative in only 36 dissertations (58.1%) with accurate titles and labels in only 17 (27.4%). Statistical tests fulfilled the assumptions only in 29 studies; with evident misuse in 33. Ten dissertations reported non-significance regarding their primary outcome measure; the median power of the test was 35.5% (range: 6-60%). There was no significant change in the characteristics between the time periods. Conclusion: MD dissertations at NCI have many epidemiological and statistical defects that may compromise the external validity of the results. It is recommended to involve a biostatistician from the very start to improve study design, sample size calculation, end points estimation and measures.

Nuclear and cytoplasmic features in the diagnosis of banal nevi, Spitz nevi, and melanoma.

BACKGROUND: Many authors have described cytologic features in a variety of melanocytic lesions but, to our knowledge, a statistical analysis of sensitivity, specificity, and overall accuracy of these features alone or in combination has not been performed. OBJECTIVE: We sought to determine the diagnostic value of nuclear and cytoplasmic characteristics in the diagnosis of melanocytic lesions via multivariate statistical analysis. METHODS: This is a retrospective observational study conducted on 300 melanocytic lesions. We evaluated a series of distinctive features; subsequently a multivariate model was used to determine sensitivity and specificity. RESULTS: Major features that favor a diagnosis of melanoma include: pleomorphism with enlarged nuclei, mitotic figures, notching/corrugation of the nuclear envelope, and peppered moth nucleus. Features with intermediate value include: solid hyperchromasia, vesicular nucleus with single round nucleolus, and nuclear/cytoplasmic ratio greater than 4:1. LIMITATIONS: Limitations of this study include its retrospective nature, and the reliance on the original diagnostic classification of each neoplasm. CONCLUSION: Our data suggest that some nuclear alterations have greater value in the diagnosis of benign and malignant melanocytic lesions.

Survival and prognostic factors for hepatocellular carcinoma: an Egyptian multidisciplinary clinic experience.

BACKGROUND: Hepatocellular carcinoma (HCC) is a dismal tumor with a high incidence, prevalence and poor prognosis and survival. Management of HCC necessitates multidisciplinary clinics due to the wide heterogeneity in its presentation, different therapeutic options, variable biologic behavior and background presence of chronic liver disease. We studied the different prognostic factors that affected survival of our patients to improve future HCC management and patient survival. MATERIALS AND METHODS: This study is performed in a specialized multidisciplinary clinic for HCC in Kasr El Eini Hospital, Cairo University, Egypt. We retrospectively analyzed the different patient and tumor characteristics and the primary mode of management applied to our patients. Further analysis was performed using univariate and multivariate statistics. RESULTS: During the period February 2009 till February 2013, 290 HCC patients presented to our multidisciplinary clinic. They were predominantly males and the mean age was 56.5 ± 7.7 years. All cases developed HCC on top of cirrhosis that was mainly due to HCV (71%). Most of our patients were Child-Pugh A (50%) or B (36.9%) and commonly presented with small single lesions. Transarterial chemoembolization was the most common line of treatment used (32.4%). The overall survival was 79.9% at 6 months, 54.5% at 1 year and 22.4% at 2 years. Serum bilirubin, site of the tumor and type of treatment were the significant independent prognostic factors for survival. CONCLUSIONS: Our main prognostic variables are the bilirubin level, the bilobar hepatic affection and the application of specific treatment (either curative or palliative). Multidisciplinary clinics enhance better HCC management.

The efficacy of a Hansenula-derived 20 kDa pegylated interferon alpha-2a in the treatment of genotype 4 chronic hepatitis C.

Pending the emergence and approval of an effective interferon-free regimen, pegylated interferon will remain an integral part of the treatment of genotype 4 hepatitis C virus (HCV). A new 20 kDa pegylated interferon has been developed in a cost-saving fungal-based system and is commercialized in Egypt at a quarter to a third of the price of conventional pegylated interferon. We hereby test the efficacy and safety of this novel cost-saving interferon. One hundred ninety-three consecutive treatment-naive patients with genotype 4 HCV were treated using the following regimen: subcutaneous 20 kDa pegylated interferon 160 µg once weekly plus oral ribavirin 1,000 or 1,200 mg daily (based on body weight <75 kg or ≥75 kg, respectively) for 48 weeks. A sustained virological response (SVR) of 51% was achieved. Interim responses included rapid virological response (RVR): 54%, early virological response (EVR): 78% (complete EVR: 71%, partial EVR: 7%), and end of treatment response: 63%. The most common adverse events were flu-like symptoms, dyspepsia, anorexia, and pruritus. Treatment-related serious adverse events were encountered in only 2 patients (1%). Discontinuation of treatment due to adverse events occurred in only 13 patients (7%). Multiple logistic regression analyses revealed the following factors as predictors of SVR: RVR (P<0.001), alpha-fetoprotein

Brachytherapy boost in loco-regionally advanced nasopharyngeal carcinoma: a prospective randomized trial of the International Atomic Energy Agency.

BACKGROUND: The purpose was to determine whether a brachytherapy boost improves outcomes in patients with advanced nasopharyngeal carcinoma treated with standard chemo-radiotherapy. METHODS: Patients with nasopharyngeal carcinoma WHO grades I-III and TNM stages III or non-metastatic stage IV were eligible for this phase III study. Patients were randomized to either arm (A) induction chemotherapy, followed by external beam radiotherapy (EBRT) with concomitant cisplatin (n = 139) or arm (B), the same schedule plus a brachytherapy boost to the nasopharynx (n = 135). The EBRT doses given were 70 Gy to the primary tumour and positive lymph nodes and 46 Gy to the negative neck. The additional brachytherapy boost in arm (B) was given by either low dose-rate (LDR - 11 Gy) or high dose-rate (HDR - 3 fractions of 3.0 Gy) brachytherapy. The primary endpoint was 3-year overall survival (OS) and secondary endpoints were: local control, regional control, distant metastasis and grade 3-4 adverse events. RESULTS: 274 patients were randomized between September 2004 and December 2008. The two arms were comparable with regard to age, gender, stage and grade. 273 patients completed treatment. Median follow-up was 29 months (0.2-67 months). The effect of treatment arm, country, age, gender, WHO pathology, stage (T3-4, N2-3 versus other) and chemotherapy on overall survival (OS), disease-free survival (DFS) and local recurrence-free survival (LRFS) was studied. Stage significantly affected OS (p = 0.024) and DFS (p = 0.018) while age significantly affected OS (p = 0.014). None of the other factors studied were significant. The 3-year LRFS was 60.5% and 54.4% in arms A and B respectively (p = 0.647). The 3-year regional control rate in the neck was 59.7% and 54.3% respectively (p = 0.7). Distant metastasis developed in 59.7% of patients in arm A and 55.4% in arm B (p = 0.377). Patients with T1/T2 N + had a 3 year LRFS of 51.8% in Arm A (62 patients) versus 57.9% in Arm B (67 patients) (p = 0.343). The grade 3-4 toxicity rate was 21.6% (30/139) and 24.4% (33/135) respectively (p = 0.687). CONCLUSIONS: The addition of a brachytherapy boost to external beam radiotherapy and chemotherapy did not improve outcome in loco-regionally advanced nasopharyngeal carcinoma.

Radiation technique influence on percutaneous endoscopic gastrostomy tube dependence: Comparison between two radiation schemes.

BACKGROUND: Our aim was to determine whether percutaneous endoscopic gastrostomy (PEG) dependence was significantly different between 2 prospective trials with different radiation fractionation schemes. METHODS: Stage III or IV locally advanced head and neck squamous cell carcinomas arising from the oral cavity, hypopharynx, oropharynx, nasopharynx, paranasal sinuses, or larynx were treated using hyperfractionation (A-3 protocol) or accelerated fractionation (A-4 protocol) with chemotherapy. Amifostine was administered 15 to 30 minutes preradiation, at a dose of 500 mg/day in both protocols. It was given as an infusion over 5 to 7 minutes (A-3 protocol) or subcutaneously (A-4 protocol). Data regarding PEG placement and removal were collected prospectively. RESULTS: Thirty-five evaluable A-3 protocol patients, 14 evaluable A-4 protocol patients, and 6 patients treated per A-4 protocol guidelines, but without amifostine as they refused the medication, were included in the analysis. Pretreatment characteristics, such as sex, age, race, T classification, N classification, American Joint Committee on Cancer (AJCC) stage, were compared between the 2 groups of patients. The only significant difference between the 2 groups was AJCC stage. Thirty-five A-3 patients and 20 A-4 patients had overall survivals of 88% versus 80%, 82% versus 75%, and 66% versus 67.5% at 1, 2, and 3 years, respectively (p = .958). With regard to PEG dependence, no significant differences were seen between the 2 groups at 6, 12, or 18 months. CONCLUSION: PEG dependence was not significantly different between the 2 study groups. Type of altered fractionation scheme may not influence PEG dependence in patients treated with similar protocols. Future randomized studies are needed to confirm these findings.

Third generation triplet cytotoxic chemotherapy in advanced non-small cell lung cancer: a systematic overview.

BACKGROUND: Previous meta-analysis on three drugs combination for treatment of advanced non-small cell lung cancer (NSCLC) did not demonstrate an improvement in survival, however many of the trials included in this meta-analysis used older and less effective cytotoxic drugs. We conducted this analysis to compare the relative efficacy of third generation triplet therapy with that of standard double therapy in the treatment of advanced NSCLC. METHODS: A MEDLINE search was performed using the search terms "lung cancer" and "randomized trials". Trials not utilizing a third generation cytotoxic chemotherapeutic agent (paclitaxel, docetaxel, vinorelbine, gemcitabine) were excluded. Pooled odds ratios (OR) for the objective response and toxicity rates were calculated using the Mantel-Haenszel estimate. Pooled median ratios for median survival were calculated using the weighted sum of the log-ratio of median ratios of individual study. RESULTS: We analyzed six randomized comparative trials involving 1932 patients. Patients receiving triplet therapy had a significantly higher response rate (OR: 1.33; 95% CI, 1.50-2.23; P<0.001). Incidence of grade III/IV hematological toxicity was higher with triplet therapy. Non-hematological toxicities, with the exception of neuropathy, were similar. Median survival of triplet therapy was not significantly different from doublet (MR: 1.10; 95% CI: 0.91-1.35; P=0.059). CONCLUSIONS: Triplet therapy with third generation cytotoxic drugs is associated with higher tumor response rate at the expense of increased toxicity. Although triplet therapy had a better overall survival compared to doublet therapy, this did not reach statistical significance.

Soluble mesothelin-related protein in malignant pleural mesothelioma.

BACKGROUND AND PURPOSE: Building-up evidence suggests that soluble mesothelinrelated protein (SMRP) carries a diagnostic and a prognostic value in malignant pleural mesothelioma (MPM). Egypt suffers endemic asbestosis and thus this study was conducted to evaluate the sensitivity and specificity of SMRP in patients with MPM and to correlate this marker with known clinicopathological prognostic factors. MATERIAL AND METHODS: During the period from January 2006 till March 2008, Serum samples were obtained from MPM patients presenting to the Egyptian National Cancer Institute, Cairo University. Serum samples were provided from patients with breast cancer and from healthy individuals to function as controls. The SMRP was assayed using the ELISA technique and correlations were made with different clinico-pathological prognostic parameters. RESULTS: 83 patients (50 MPM and 33 breast cancer) as well as 22 healthy individuals were enrolled in this study. Serum SMRP levels were not different between patients with breast cancer and healthy controls (p > 0.05). However, there was a significant difference between MPM patients and the other two groups (p < 0.0001). ROC analysis showed an AUC = 0.765 for differentiating between the controls and MPM with a best statistical cut-off of 7.22nM/L (sensitivity = 66 % , specificity = 70.9 % ). The mean SMRP concentrations were significantly higher in patients with advanced disease (p = 0.038), poor performance status (p = 0.017) and high alkaline phosphatase (p = 0.015). The mean SMRP concentrations were also higher in males, elderly patients, asbestos-exposed patients, epithelioid subtypes and patients with high platelet and leucocytic counts. However, these differences did not reach statistical significance CONCLUSIONS: This study confirms that SMRP is of considerable sensitivity and specificity in Egyptian patients with MPM. Higher levels are frequently seen in patients with high tumor burden, which could be helpful in monitoring response to therapy. KEY WORDS: Malignant pleural mesothelioma (MPM) - Soluble mesothelin related protein (SMRP)- Sensitivity - Specificity - Asbestos.

Gemcitabine and cisplatin in the treatment of advanced non-small cell lung cancer: National Cancer Institute Cairo experience.

AIM OF THE WORK: The aim of the present study is to document the antitumor activity of the combination of gemcitabine and cisplatin for the treatment of advanced NSCLC, asses the nature and severity of the side effects and elicit the impact of the combination chemotherapy on progression free survival and overall survival. PATIENTS AND METHODS: From August 1997 to August 2001, we conducted a phase II study of gemcitabine and cisplatin in 60 chemonaive patients (21 stage IIIB and 39 stage IV). For the first 34 cases, gemcitabine was given at a dose of 1,000 mg/m2 IV on days 1, 8 and 15 with cisplatin 100 mg/m2 on day 15, every 28 days. In the following 26 patients, the regimen was modified to gemcitabine 1,250 mg/m2 days 1 and 8 and cisplatin 80 mg/m2 day 1, every 21 days. RESULTS: Patients included 53 males and 7 females [median age, 52 years (range, 28-69)]. Twenty-nine had adenocarcinoma, 18 large-cell carcinoma and 13 squamous-cell carcinoma. Thirty-one patients had a performance status (PS) of 2 and 22 presented with weight loss. All patients were evaluable for response. Three patients achieved a complete response (CR) and 22 had partial response (PR), giving an overall response of 41.7%, with a median duration of 10 months (range, 4-46 months). The time to progression (TTP) was 8 months (range, 2-46 months), with a median overall survival of 9 months (range, 2-46 months). The one-year survival rate was 30.3% for the entire study population, 44% for responders, and statistically improved in patients with a PS of I and those with no weight loss. A total of 255 cycles were administered (median, four cycles/patient). Myelosuppression was significant (but manageable) with grade 3/4 neutropenia in 32.6% of cases, anemia in 18.6% and thrombocytopenia in 20.4%. Nonhematologic toxicity was limited to grade 3/4 nausea and vomiting in 28.8% of cases and impaired liver enzymes in 13.6%. CONCLUSION: Inspite of the relatively poor prognostic characteristics in the study population, gemcitabine and cisplatin, was an effective combination with tolerable, manageable toxicity in advanced NSCLC.