P-504 Phase II study of gemcitabine-vinorelbine followed by docetaxelin elderly patients with advanced non-small cell lung cancer

Posters I Non-srnafl ceil lung c a n c e r - Advanced disease (II/BIIV) and gemcitabine 1000 mg/m 2 at a rate of 10 mg/m2/min on days 1 and 8 of a 3 week cyde No previous chemotherapy was allowed Prophyla~c G-CSF was not used. but was allowed on subsequent cycles for Grade III or IV neutTopenia causing tTeatment delays of for neutropenic fever Patients had repeat imaging (CT or MRI) after avery 2 cycles to evaluate for response Results: A total of 14 patients ware enrolled, with a median fcllew-up of 11 months One patient did not receive treatment due to a pre-therapy decline in performance status The 13 remaining patients received a median of 3 6 cydes of chemotherapy with a partial response rate (PR) of 23.1%. Fifteen percent of patients progressed on therapy while 61.5% had stable disease (SD). for an overall clinical benefit (SD+PR) of 84%. Median progression free survival was 8 months and meclan survival was 18 months. The one year sur-vIval was 46%. The major tosic~ty was myelosuppression with 54% of patients exgenenclng grade III of IV neutrppenia at some point dunng their treatment. One patient died secondary to neut]-openic sepsis. Another patient died on protocol of cardiac causes not thought to be related to chemotherapy Two palJents had paralytic ileus eady in the study prompting a change in the protocol vinorolbine dose from 30mg/m 2 to 25mg/m 2. No episodes of ileus occurred at the 25 mg/m 2 dose Conclusions: The doublet of vinorelbine and prolonged infusion gemcitabine for advanced NSCLC in the elderly appears to be wall tolerated, though prophylactic G ~ S F should be considered The partial response rate of 23 1% is similar to previous ~als that have evaluated this combination. Patients on this thai had a favorable median overall survival and time to progression. [~"

Outcome of patients with stage III and IV non-small cell lung cancer In Marmara University Hospital, Istanl~JI, Turkey

M. lylkeslo. R YUmL~. F. Dane. M. Ekenel. G. Basaran. N. Tur'hal. Dtvtston ot Once/ogy, Mariners Umveretty Medca/ School Hosptta/, lstantm/, Turkey

Background: Nor. small cell lung canosr (NSCLC) is the most common cancer in men. aocounting Ibr 18% of all cancers on a worldwide basis. Lung Cancer is one of the five most diagnosed canosrs in Turkey as in the wodd. The treatment outcomes of 236 advanced and metastatic NSCLC patients who were treated in Marmara University Oneology Clinics between Apnl 1g97 and January 200`5 were evaluated Methods: All palJents were diagnosed histologically or cytologically and staged with CAT scans Mediastinosoopy and nuclear bone scans were used in appropriate eases All patients with performance status (PS) 2 and lower received chemotherapy In 183 patients, a platinum analogue was used in combination v~th etoposide, vlnerelbine, gem~abine or texans as the first line b-eatment. Thirty seven eldedy (65 years and older) or poor PS patients (PS= 2) ware treated with single agent chemotherapy either with platinum analogues or vinorolbine. Three to 6 cycles of treatment was administered depending on clinical or radiological response. Radiation therapy to primary tumor was administered to 39 stage III patients after completion of first line chemotherapy and to 16 symptomatic stage IV patients for palliation. Eligible stage IliA patients (10%) were operated Second line tTeatment was offered to 65 (30%) patients with progressive disease ~r 3 to 6 cycles whose PS was 2 and lower Results: Median age was 60 years (range: 28 87) and 140 patients (77%) were male Histological subtypes were squemous cell in 34%. adenoearclnoma in 32%. NSCLC in 32% and large cell cancer 2% PS was 0 in 62% of the patients Twenty-seven (11%) of the patients were stage IliA. 61 (28%) were stage IIIB. and 148 (63%) were stage IV The median number of cycles administered was 3. At a median follow up was 10 months (range 1-67). 143 (61%) patients died and 178 patients (78%) progressed. Median overall su~val (OS) was 15 months. 1year OS ratio was 38%. Median time to progression (TIP) was 5 months. 1year progression free survival (PFS) ratio was 26%. Women. patients with adenoca~noma histology, stage III disease. with operable disease and who received primary raclotherapy lived significantly longer (p 0002. p 002. p 001. p 002 and p 0002. respectively) NeIther age. nor PS (0 vs 1 2) had any statistically significant effect on survival in univadate analysis Gender. stage and pnmary radiotherapy to the tumor were independent factors influencing the OS (p 0 01). while only stage had an impact on PFS Conclusion,=: Advanced staged NSCLC patients has poor prognosis, in spite of vanous tTeatment modalities Our results are consistent with the wodd literature. ~3T

Smoking history, and serum NSE level as prognostic factors In the adenocardnema of lung carw.er paUants

T. Jang ~. H. Kim ~. C. Ok ~. J. Ryu 2. M. Jung ~. ~Kosm Untversrty College ot Medicine, Busan, South Korea: 2Untversrty ct tnha C,etlege ot Medicine, South Korea Background: The incidence of lung adenoosrcinema is increasing recently in total lung cancer. The aim of this study was to investigate the prognestic factors for the patients with lung adenocarclnoma. Material and method: We performed the rotrospectWe review of clinical information that diagnosed as adenocarcmema of lung at Kosin Un~ve~ty

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Gospel Hospital. Busan. South Korea from 1994 to July 2004. Patient's demographics (age. gender), performance status (by ECOG grade), weight loss. smoking history, the location of lesion, stage, serum tumor markers, and tTeatment methods at the time of diagnosis ware analyzed Results: For all 422 patients with adenoosrcinoma of lung. 247 (,58 ,5%) were male. and mean age was ,sg 8 years old There was increased percentage of nonsmokers (58. 3%). peripheral form (`58 3%) The number of central form in smoker group (42 8.%) was Pdgher as compared to nonsmoker (31 9%). but this was not statistically s~gnifK:ant (p= 0.12). In urlvanate sur-vIval analysis. age. gender, weight loss. smoking status, stage of disease, serum CEA (carclneembryonic antigen) and NSE (neuron specific enolase), and treatment methods ware statistically s~gnifK:ant prognostic factor. By multwarlate analysis. age. stage, smol~og status, and treatment methods were found to be independent preclctors of survival. Concluslons"Smol~og status was important progeostic factor, and so the survival difference of gender was to be influenced by smoldng It was also ~und that serum NSE level, as tumor maker, was independent prognostic factor

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Phase II study of gemcltablne-vlnorelblns followed by docetaxsl In elderly paUants wlth advanced non-small cell lung cancer

E Josd-Luis ~ E Gasper 2. V Sergio ~. P Eva ~. L Cdstlna 2. L Luis 4. A Margarita ~. G. Cados 6. S. Merosdes I . M. Jos~Rambn 3. lMedtcai

Onco/ogy, C H Orense, Spain, 2HospitaJ de EJda, Spain, ~ C H Lugo, Spain, 4CH. Sent]ago, Spa/n: ~C.O.G. Coru/]a, Spa/n: ~H. MetxoettlO, V/go, Spain Gematabine (G) and Vlnorolbine combination is active for advanosd NSCLC. In addition, single agent Docetaxel ([3) is also active especially a a second line therapy: We conducted a phase II study to determine the efficacy and safety of this seguential nen~latinum thplet in elderly pts wlth advanced NSCLC. Chemo~aive pts (age > 70 yrs. stage I IIB IV. PS 0-1. adequate organ functions and signed in~rmed consent) were elegible ~r this study The treatment regimen was 2 cycles of G 1000 mg/m 2 and V 25 mg/m 2 (days 1 and 8 avery 3 weeks) followed of 2 cycles o l D 60m~'m z (day 1 avery 3 weeks) To date 28. pts have been enrolled and 90 cycles assessed Male / Female 23/5: median age: 76 y (range: 70 86): PS 0/1: 3/2`5: stage IIIB/IV: 12/16:14 Squamoos cell carcinoma. 10 adenoosrclnoma and 4 large-cell carcinoma At the time of this preliminary analysis. 23 pts are avalueble for tmdcity and 22 Ibr response. PR: 8/22; SD: 6/22 and PD: 8/22. The overall response rate was 38% (95%C1: 16% 56%) The main haematclogical tosiclties were grade 3-4 neutropenia in 3 pts and grade 3 anemia in 1. Non~aematological grade 3-4 toxiclties were grade 3 asthenia and grade 3 constipation in 2 and 1 pt respectively. These preliminary results suggest that the sequential GVO C(XTlbination is active and well tolerated in elderly pts with advanced NSCLC.

[ P ~ 5 ] Comparison of three chemotherapy regimes for Inoperable non small cell carcinoma K. Govind Babu. P. Bapsy. M. Ginsh. K. Prabssh. C. Hartta. S. NimIt.

ABHAYA, Bangalore, tnSta InlToductlon: Lung cancer is the leading cause of cancer death among men worldwide. The incidence of lung eanosr in Bangalore among men is 495 per 100.000 population. The maJonty of patients with Stage III B or IV NSCLC can net be cured with current therapy. Thus. palliation and prolongation of life are the pnmary goals oftTeatment Cisplatln has emerged as the main stay in the chemotherapy of lung cenoer with a 13 to 30% objective response rate Vanoos inciviqual studies as well as mete-analyses o cieplatin based chemotherapy compared with best supportive care in NSCLC have shown a definite benefit of chemotherapy However. the absolute benefit on survival was modest In one of the mete-analysis increase in median survival was 1 5 months This modest survival benefit has prompted the use of newer cytotoxic agents with potentially increased effK~cy and fewer side effects. Among these one is Gem~abine. which acts as competitive substrata for incorporation into DNA. where It leads to chain termination. The other group is taxanos which act on microtubules and prevents cell proliferation. In this study we are shanng our expenenos with throe c~splatin~ased regimens. Alms and Objectives: To compare the efficacy of throe widely used platinum regimens in advanced NSCLC patients - To compare the toxicity of these chemotherapy regimens - To assess pharmaco-econemics PaUants and Methods: This is a rotTospective comparative analysis study Sixty new cases of advanced or metastatic NSCLC palJents tTeated at KMIO between lan l gg9 to Feb 200 were included Twenty patients received Paclitaxel and cisplatin (P+C), twenty patients received Gemcitabine and clsplatin and remaining twenty raoslved Etoposide and clsplatin. Patients included in the study had a Karnofsk'y perforrnanos score more than seventy, normal hemogram, renal and hepatic function. At least one measurable lesion was present. Patients with CNS metastasis ware escluded from the study.