Poster Session I/Chemotherapy: NSCLC 1 s97 chemotherapy with further improvement of response in 3. At a median follow up of 15,4 months the 1 year overall survival is 74%. GP regimen appears feasible and well tolerated in elderly pts when PS and comorbities are taken into ac- count for tailoring doses. Age should not limit the access to standard P-based chemotherapy in elderly allowing this subset of pts to gain the same benefit expected for younger pts. El P 24 Documentation of benefit from chemotherapy in advanced NSCLC Shane C. White, Paul Mitchell. Ludwig lnstitufe for Cancer Research, Austin-Repatriation Medical Centre, Heidelberg, Australia Introduction: The ongoing dilemma of chemotherapy in NSCLC is to balance quality of life and survival against the toxicity and economic cost of treatment. This audit retrospectively assessed the quality of documentation in patients with advanced NSCLC receiving chemotherapy. In patients who have only stable disease (SD), indicators of benefit were sought to justify treatment continuation. Methods: ARMC records of 28 NSCLC patients were examined retrospec- tively. The notes were reviewed for documentation of response, symptom ben- efit, weight, performance status and toxicity of treatment. Results: The median age was 64 years, and 22/28 were Stage IV (79%), 4128 (14%) was Stage IIIA, and 2/28 (7%) was Stage 1118. There was a median of 4 cycles of treatment. In total, the 28 patients received 118 cycles of chemother- apy. The unconfirmed response rate was 12%. 19/28 patients (68%) had at least 2 episodes of symptom documentation. of the 13 patients who had SD, IO had serial documentation of symptom change. Eight of the 13 patients had improved symptoms, 1 had stable symptoms, and 1 patient had symptomatic progres- sion.17/28 patients (61%) had at least 2 serial episodes of documentation of performance status. lo/13 patients with SD had serial documentation of perfor- mance status change. Five of the 13 patients had a stable performance status, 3 had improved symptoms and 1 patient had symptomatic progression.l2/28 patients (61%) had at least 2 serial episodes of documentation of weight. 8/13 patients with SD had serial documentation of weight change. Four of the 13 patients had a stable weight (< kg), 2 patients gained weight (> 1 kg) and 1 pa- tient had lost weight (> lkg).12/28 patients (61%) had at least 2 serial episodes of documentation of toxicity. 1 O/l 3 patients with SD had serial documentation of toxicity. .The patients with SD appeared to have better documentation. The majority of these patients had evidence of benefit such as reduced symptoms or weight gain, encouraging the continuation of chemotherapy Conclusion: In conclusion, the low response rates and the side effects of treatment necessitate careful assessment of all patients receiving palliative chemotherapy. The adherence to an agreed standard of documentation may impact positively on patient care. El P 25 Feasibility trial of protracted (120’) Gemcitabine infusion in Non-Small Cell Lung Cancer (NSCLC) Rosana Grandez, Javier Martinez, M6nica Corral, Teresa PuBrtolas, Abigail Ruiz de Lobera, Ana Herrero, Juan Lao, Vicente Alonso, Antonio Ant6n, Angel Artal-CortBs. Hospital Universitario Miguel Servet, i’aragoza, Spain Gemcitabine (Gem) is active in NSCLC both as monotherapy and in combi- nation. Clinical development was based on short-term weekly infusions. How- ever, preclinical studies showed an schedule-dependent activity as the cyti- dine kinase is saturated at conventional doses. Prolonged infusion may yield higher intracellular dFdCTP concentrations and a dose-rate fixed infusion (10 mg/m’/min) has been advocated as more efficacious and already tested in other malignancies. Aim: To assess feasibility (activity and toxicity) of this schedule in metastatic NSCLC. Patients and Methods: Patients (p) with advanced (not amenable to local therapy) NSCLC were eligible. Previous chemotherapy (CT) was allowed. CT schedule: Gem 1200 mg/m2 over 120 minutes infusion was given days l&8 every 21 days. Courses were repeated until progression or toxicity up to a max- imum of 8. 25 patients have been included. Patient Characteristics: 21 p (81%) were male. Median age 67 years (range 52-80). PS 0 4%, I 60%, 2 36%. Significant weight loss 68% of p. Histol- ogy: Squamous 36%, Adenocarcinoma 48%, Undifferentiated 16%. Stage IV 92%, median number of metastatic sites 2 (l-4): most frequent sites lung 80%, liver 28%, CNS 16%. Prior CT (platinum-containing) 8p. CT administration.- 92 courses have been given (median 4, range I-8). 6 doses were omitted or re- duced. Response was assessed in 18~ (too early in 6): Partial response 3p (16.6%), stable lop (55.6%), progression 5p (27.8%). Toxicity was mild and consisted of: diarrhoea (G3 1p, G2 2p), anaemia (G3 3p, G2 1 p), asthenia (G3 Ip, G2 Ip) oral mucositis (Gl lp) and skin rash (Gl Ip). Median time to pro- gression was 20 weeks. Median survival 28 weeks. Conclusions: Gem 1200 mg/m2 over 120 minutes infusion was feasible with very low toxicity. Toxicity profile was different from the usual 30 minutes admin- istration. Significant activity was seen despite the unfavourable characteristics of the patients here included and combining this schedule with cisplatin is war- ranted. El P 26 Phase II trial with RFS 2000 (9NC) in patients with advanced and/or metastatic non-small cell lung cancer (NSCLC) Sofia Baka’, Paul Lorigan’, Sarah Danson3, Alison White4, Patrick Joyce2, Nick Thatche?, Malcolm Ranson3. ’ Christie Hospital Manchesfer, Manchester, England; 2 Weston Park Hospital, Sheffield, England; 3 Christie Hospital, Manchester, England; 4 Crisfie Hospital, Manchester, England RFS 2000 (9 nitrocamptothecin, Rubitecan) is a new topoisomerase I inhibitor which has shown significant activity in melanoma, breast and ovarian cancer. We report a phase II study of RFS 2000 as first line treatment in NSCLC. 17 treatment naive patients with stage Ill (g/17) and IV (8/17) NSCLC (11 male and 6 female) were treated, the median age was 62 years (range 52-86), and the majority of patients were of PS 1. Treatment was given orally, daily for 5 days, repeated every week. The starting dose was 1.5 mg/m*/d, and more es- calation was permitted guided by toxicity. 15 patients had a dose escalation to 1.75 mg/m*/d, and 7 had a second dose escalation to 2.0 mg/m*/d. The 2 pa- tients who did not have a first dose escalation were withdrawn from the study for progression of disease. The 8 patients who did not continue to a second dose escalation were all withdrawn for disease progression or disease related symp- toms. RFS 2000 (g-NC) was well tolerated. Almost all adverse events were mild to moderate (grade 1 and 2). Most frequently reported adverse events, were diarrhoea 10/17, nausea 13/17, anorexia 5/l 7, and lethargy 5/17. Neutropenia and thrombocytopenia were not observed in any patient. Anaemia (grade 1) was reported, in two courses. There were no responders to treatment but lo/17 patients had stable disease. Five patients progressed on treatment. Two pa- tients were not evaluable for response (received ~4 weeks of treatment).l2/17 patients had thoracic radiotherapy post Rubitecan, 3/17 have been treated with 2nd line chemotherapy and 2117 had no other treatment.15 (88%) patients have since died. The median survival time is 257 days (95% ci, 222-352). It was con- cluded that the initial dose level of 1.5 mg/m*/day (level 0) was too low for this treatment-naive patient population with NSCLC. Further studies at an increased dose are required. El P 27 South American Experience with a 3-week regimen of Gemcitabine(GEM) and Cisplatin (CIS) in advanced NSCLC: Preliminary results Rodolfo Gomez’, Daniel Lee Kav Per?, Sergio Poli3, Alejo Jimenez4, Jose lgnacio Martinez’, Eliecer Payares”, Zulay Pastran’, Carlos Ortiz*, Javier AfonsoQ, Sergio Santillana’. ’ Clinica Las Americas. Medellin. Colombia, Medellin, Colombia; “E/i Li//y Co., Lima, Peru; 3 Hospital Universitario Caracas, Caracas, Venezuela; 4 Clinica Las Americas. Medellin, Medellin, Colombia; 5 lnstituto National de Cancerologia - Bogota, Bogota, Colombia; 6 lnstituto de Oncologia de Valencia, Valencia, Venezuela; 7 Hospital Domingo Luciani. Caracas, Caracas, Venezuela; a Hospital Universitario San Ignacio, Bogota, Colombia; ‘Hospital Razzefti Caracas, Caracas, Venezuela Background: Combination of GEM/CIS is a standard first-line treatment for ad- vanced NSCLC. Modifications of the original 4-week regimen with CIS at doses of 100 mg/m* have been tested to improve the toxicity profile of the combi- nation. We performed a phase II trial to evaluate the efficacy and toxicity of a Pl-day regimen of GEM/Cl& with a reduced dose of CIS 75 mg/m2 on day 1. Patients and Methods: Eligibility criteria included histologically or cytologi- cally proven stage IIIB and IV NSCLC patients over 18 years old with a Karnof- sky performance status (KPS) 360 and no prior chemotherapy treatment. The regimen consisted of CIS 75 mg/m’ on day 1 and GEM 1000 mg/m2 on days 1 and 8, repeated every 3 weeks for 6 cycles or until progression. Results: From January 2001 to December 2002, we enrolled 41 patients stage Ill-(16) or IV(25),in Colombia and Venezuela. of the 41 patients, 6 were excluded due to progressive disease (l), acute renal failure (toxicity) (1) and patient refusal (4). However, all 41 patients were evaluable for intent-to-treat analyses of toxicity and efficacy. Median age was 58 years (range, 34-78), with IO/31 females/males. Predominant histology was adenocarcinoma (in 46% of patients). KPS was adequate (>90 in 44% and ~70 in 15% of patients). Only 23/41 (56%) patients finished the 6 planned cycles. Overall response rate was 63.4% (26/41) (95% Cl, 45%-82%), with CR in 9.8%(4/41), PR in 53.7% (22/41), and SD in 14.6% (6/41) of patients. Only 3 patients progressed during treatment. The toxicity profile was favorable with WHO grade 3 hematological toxicity in only 4% of patients and grade 4 thrombocytopenia in 1 patient; addi- tionally, 1 acute renal failure and 3 hospitalizations for toxicity (2 for acute renal failure and 1 for hematological toxicity) occurred. Conclusions: Our preliminary report suggests that this modified GEM/CIS schedule for advanced NSCLC produces similar efficacy results in terms of response rates than those observed with classical 4-week regimens of