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17017 Background: Oral cancer is a major problem in India. Most of these patients present with locally advanced disease not amenable to upfront surgery. The treatments of these patients are often c...

20710 Background: The long duration and frequent administration of chemotherapy in cancer patients requires long term venous access. Subclavian central venous catheters (SCVC) and peripherally inse...

17077 Background: The cancer load in India is enormous and majority of the cases present in an advanced stage. There is no valid translation of 12-item General Health Questionnaire (GHQ-12) in Kannada, which is a simple but indispensable tool in the comprehensive cancer care (both for metastatic and in adjuvant settings). Therefore we thought of developing and validating the GHQ-12 Questionnaire into Kannada language. Methods: The study was conducted at kidwai memorial institute of Oncology, Bangalore, a tertiary cancer center with an annual attendance of 16,000 new cases. We have chosen educated patients who can speak and write both English and Kannada. We used ’forward-backward’ translation procedure into Kannada. We used scores from 0–3 for the Questionnaire. Total score for both languages was calculated. Internal consistency was assessed by Cronbach's alpha coefficient. Validity was performed using convergent validity. Finally, the factor structure of the questionnaire was extracted by performing principal component analysis using oblique factor solution. Results: A total of 118 patients with various malignancies were entered into the study. The mean age was 36.8 ± 12.1 years. The mean GHQ score was 21.6 ± 9.1 for the English and 22.6 ± 8.1 for Kannada. Reliability analysis showed satisfactory result (Cronbach's alpha coefficient = 0.79). The principal component analysis with oblique rotation solution showed that the GHQ-12 was a measure of psychological morbidity with four -factor structure that jointly accounted for 48 % of the variance. Conclusions: The Kannada version of the GHQ-12 is a reliable and valid instrument with a good structural characteristic. It can be used for measuring psychological well being at our institute for those patients who can read and write only Kannada. No significant financial relationships to disclose.

11043 Aim: To analyze the efficacy, tolerability, toxicity profile, quality of life, survival rates and pharmaco-economics of TAC vs. FAC in women with ER/PR positive breast cancer and >4 involved lymph nodes. Methods: 100 patients with >4 node-positive breast cancer were randomly assigned to receive either 6 cycles of taxane-based (TAC) or anthracycline-based (FAC) adjuvant chemotherapy. All the patients received adjuvant radiotherapy and hormonal therapy after completion of chemotherapy. The primary end point was to assess disease-free survival (2 years), toxicity profile, QOL and to analyze the pharmaco-economics of both therapies. All patients completed EORTC QLQ 30, BR 23 questionnaire before randomization and before every cycle of chemotherapy. Pharmaco-economic feasibility was determined using cost of drugs, duration of hospital stay, laboratory investigations, management of complications and loss of wages. Treatment: The treatment (dose in mg/m2) was as follows: TAC: docetaxel 75, doxorubicin 50, cyclophosphamide 500; CAF: 5 flourouracil 500, doxorubicin 50, cyclophosphamide 500. Results: The patient demographics and primary tumor characteristics were comparable in both the arms. Taxane- based regimen was associated with decreased global QOL and physical function. The cost of TAC regimen was 25 times more than FAC regimen. Conclusion: Although TAC regimen had longer DFS as compared to FAC, it was associated with a higher incidence of side effects and increased duration of hospital stay. Further, high cost precludes its wide-spread use, and FAC regimen still continues to be the first choice treatment of high-risk node and receptor-positive breast cancer in a third world country like India. [Table: see text] No significant financial relationships to disclose.

17539 Background: One of the common toxicities observed with small molecule tyrosine kinase inhibitors are skin rashes, which were proven to predict the response to therapy in cases of lung cancer (Ann. Onc., 2005; 16(5): 780 - 785). However, very few have evaluated the same in patients with chronic myeloid leukemia (CML) on treatment with imatinib. Therefore we thought of doing a prospective study to evaluate skin rashes, and compare it with the clinical, hematological, cytogenetic and molecular remission rates in CML patients on Imatinib therapy. Methods: It is a non randomized, prospective study conducted at a tertiary care cancer center with an approximate attendance of 15,000 new cases. The patients were stratified into those who had skin reactions and do not. CTC version 3.0 was used to assess the skin toxicity. Differences in the proportions were calculated with the help of Medcalc Version 7.5. Results: A total of 314 patients with CML were evaluated who were on regular treatment with Imatinib. Hematological response was assessed monthly, cytogenetic analysis (available in 212 patients) at the end of 3rd month and molecular response (available in 136 patients) at the end of 6th months respectively. The response rates in two groups are as follows. *Percentages calculated for the subset of patients in whom results of either cytogenetic or molecular response are available Conclusion: Our findings suggest that skin reactions are not a good marker to predict either response rates or progression free interval in cases of CML. This is further substantiated by the findings that the percent of skin reactions in west are far less compared to our results, who had a better molecular as well as cytogenetic responses. [Table: see text] No significant financial relationships to disclose.

16522 Background: Skin reactions are observed in up to 30–45% of all patients of CML on imatinib therapy. Owing to its low molecular weight it is less likely to be immunologically mediated. Therefore most of them can be managed without discontinuation of therapy. We tried to look into the spectrum of the skin reactions observed in CML patients receiving imatinib, and tried to see any change with the phase of the disease (chronic/accelerated/blast crisis) or difference in the brand of drug they are receiving. Methods: This retrospective study was conducted at Kidwai Memorial Institute of Oncology, Bangalore, India. A total of 235 patients were analyzed between Jan 2004 and Dec 2005. Clinical details were noted from the case records. Differences were calculated for the means using SPSS 13.0 for windows. Results: The age, total episodes of reactions, mean time to develop and to heal along with grade of reactions are summarized in the table . A total of 191 patients received the international brand and the total episodes of skin reactions observed were 68 with 4 grade III/IV toxicities. 54 patients received local brand and 17 of them developed skin reactions and 2 of which were grade III/IV. There is no difference in the time taken for resolution of skin reactions (23.8 + 6.7 vs. 25.2 + 7.5) (p = NS). Conclusion: There are no significant differences in skin reactions observed with brand of imatinib used. Patients with accelerated phase and blast crisis developed reactions at little earlier. As most of the patients in the later said conditions had a shorter survival, we could not comment conclusively on the time to heal according to phase of the disease. [Table: see text] No significant financial relationships to disclose.

14638 Purpose: Retrospective comparison of treatment out come and cost effective analysis in two chemotherapeutic regimens (BEP vs. VIP) for poor-prognosis metastatic germ cell tumors in India, a resource poor nation. Methods: All male patients with poor risk germ cell tumors were included in the study between 2001–2003. The patients were stratified into two categories depending on the type of the regimens they received. Results: Finally 36 patients were analyzed with median follow up of 21.8 months. Medical 7.5 for windows was used for the analysis. The baseline characters (age, stage, PS, histology and serum markers) were not different in two treatment arms (P > 0.05). The different treatments (BEP vs. VIP) had no statistically significant influence on the outcome. VIP is less cost effective and more toxic compared to BEP. Conclusion: In view of absence of survival advantage and more toxicities as well as cost of therapy it would be appropriate to still treat the patients of high risk germ cell tumors with the conventional BEP rather than VIP in the Indian setting and keeping the later reserved for the relapse. [Table: see text] No significant financial relationships to disclose.