P-227 Concurrent chemoradiotherapy with cisplatin and vinorelbine in locally advanced non-small cell lung cancer

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Posters/Combined moda/ity therapy for NSCLC

(IC:9.7-18.4) months. For the17 pat]onts still alive the median follow4Jp was lg months All evaluations were done considenng c~ 0 05 Conclusion.=: concurrent chemoraciotherapy with Navelbine and Cisplatin followed by consolidation ChT with the same drugs given for advanced stage III NSCLC is feasible and well tolerated and has a positive effect on the RR and S Keywords: concurrent chemoradiotherapy, advanced NSCLC[Click here to type Background section]

[P~A

phase II study of concurrent ctlemoradlotherapy wRh navalblne and clsplatln for unreeectabla stage III NSCLC

P R u s u I T Ciuleanu 2. D Cornea I . D Pelau ~ . V Gaal 1.C Cebotaru ~. T Guttman ~. N Toder ~. N Ghilezan I llns~tute of E)ncology C/uj-Napoca, Cluj4Vapoca, Roman/a, 2 Un/versrty of Mad/c/ha ~tu//u Hat/aganu", C/ujNapoca, CtujNapoca, Romama

Bact(ground and purpose: Preponderenca of evidence supports concurrent chemoradiotherapy as the prefered opt]on in unresoctable locally advanced NSCLC. We prezent the further results of a prospective phase II study to determine the response rate (RR). toxicity, time to progression (]qP) and survival (S) of concurrent Nevelblno and Cisplat]n. with radiotherapy (RT). followed by consolidat]on chemotherapy (ChT) with the same drugs, for locally advanced stage III NSCLC. The role of protectors like amifost]ne has been evaluated Method,=: 5?" pat]ents (pts) with i'tstologically proven NSCLC. stage Ilia and IIIB. PS 1 2. measurable disease, adequate hematologic, renal and hepatic func~ons were included the study from 16 11 2000 to 18 09 2003 Pat]ant characteristics were: median age,56 (44-7"1). M/F 49/8. PS 1/2 27/30. stage IIINIIIB 11/46. squamous cell co 44. adenoco 7. adenoid dnlstic cc 1. large coil cc ,5 The treatment consisted of 2 o/cles of ChT with Nevelbine (l,sm~'sqm. d 1. 8. q21) and Cisplatin (80 mg/sqm, d 1. q 21). given concurrently with RT (56-60 Gy/28-30 fi'actions/6 weeks), followed by 2-4 cycles of consolidation ChT with the same drugs (Navelbino: 2,5 mgtsdm dl. 8. Cisplatin 100mgtsqm. dl. q 21). 22 pts. recawed amifest]no 740 mg/sqm, dl. 8. q 21. ChT has been completed by 65% and RT by 79% of lots. Results: 57 pts. wore ovaluable Ibr t~icr~y. Grade 3 or 4 neut]-oponia oocured in 11 pts. (19%). esophagltls in 11 pts. (19%). digest~o t~ic~es in 10 pts. (17%) There was atTend of lower severe esophagitls when Amifostine was administTated Of the 55 pts evaluable for response. 13 actieved a complete response (CR 23 64%. IC:12 4 34 9). 22 achieved a papal response (PR 40%) for an overall response rate (RR) of 63 64% (IC: 50 9 ?'6 4%) 16 pts had stable disease (SD 29 09%). and 4 pts had progressive disease (PD 7 27%) T I P survival curves showed 1- and 2- year values of 42% and 21% (IC: 11 36%) respectively and a median value (m "I-FP) of 10 5 (IC:8 1 15 3) months. The l~and 2 year disease specific S rate was 58% and 29%. the median S was 15 (IC:9.7-18.4) months. For the17 pat]ants still alive the median follow4Jp was 19 months. All evaluations were done considering e = 0.05. Conclusions: concurrent chomoraciotherapy with Navelbino and Cisplatin followed by consolidat]on ChT with the same drugs given for advanced stage III NSCLC is feasible and well tolerated and has a positive effect on the RR and S.

[P•

The long-term results of a pilot study of three times a day radiotherapy and escalating doses of dally clsplatln for locally advanced non-small call lung cancer

S. Schild, W. Wong, S. Vora, M. Halyard, D. Northlblt, H. Kogut, R. Wheeler. Mayo Ct/n/c, USA

Background: This analysis was perlbrmod to determine the long term results of a phase I t]lal which included three times a day radiotherapy (TID RT) and concurrent daily c~splat]n (CDDP) for stage III non small coil lung cancer (NSCLC). Methods: Twenty patients with stage III NSCLC were t]'eated wlth TID RT delivered over 12 weekdays which included ,57.6 Gy administered in 1.5 Gy fractions at 8 a.m. and 4 p.m.. and l.SGy fractions at noon. AP: PA fields were used at 8. a m & 4 p m Opposed oblique off cord fields were used at noon The first ,5 patients were given no CDDP. the second ,5 patients received 5 mg,'m2 of CDDP. and the remaining 10 patients received 7.5 mg/m 2 of CDDI~ All survivors were followed for greater than 5 years. Results: The maximum tolerated dose (MTD) of daily CDDP during this program of RT was 7 5 mg/m 2 None of the patients died as a result of toxicity The median survival was 192 months and the 5-year survival rate was 25% Tumor response and patterns of failure were also evaluated Conclusions: Tils study was performed to determine the MTD of CDDP when administered daily dunng an aggressive program of TID RE The survival results appeared premising suggesting the combination of TID RT and systemic therapy deserves further study.

[P-~6] Multlaentra phase II t]'lal of accelerated high dose eplrubl¢ln and ¢lsplatln followed by surgery In pstlents ~ locally a¢lvanaa=d non-,=rnall call lung cancer E Smit ~,~ B Biesma 2. M Paul I . A van der Tel ~. F Schremel 4. R Bolhuis 2. P. Postmus ~. ~Vnja Umvers~tatt Mad/ca~ Centre, Amsterdam, The Nathetlanas. 2Jeroen Bosch Ziekenhu~s, Den Bosch, The Netherlands, 3Ma~ni Ziekenhuis Groningan, The Netherlands, ~St Antonius 7Jekanhuis, Nieuwagein, The Netherlands A multlcontre phase II ~al investigated the efficacy of neoadjuvant cisplatln and high dose epirubicln in an accelerated schedule in patients with locally advanced NSCLC. Pts and mathods: Slxty~ono patients with previously unt]'eatod potentially operable stage IIIA~N2 NSCLC received 3 cycles of cisplatln 60 mg/m 2 and oplrubicln 135mg/m 2 day q 2 weeks with GCSF day 3-12 and erythropoiot]n support. Restaging consisted typically of CT and PET scanning. endosophagoal ulb'asoued with FNA or remodiastinescopy. In pts with no evidence of mediast]nal involvement surgical resection was attempted. Results: 61 pts (44 male. 17 female) with a mean age of 62 (range 40 79) years. ECOG PS 0:1 17:44 were included from Jan 2001 - A p r 2004 Distribution o f t stages was: Tx 3. T1 8. T2 39. T3 11 Three pts were ineligible: 2 with M1 and 1 N3 disease Six pts are NE for various reasons, inducing pt refusal after 1 course of Cx i n 4 pts Mecian number coLrses chemotherapy 3 (range 1 4) with 7 pts receiving <3 courses Mecian RD1100 (range 2,5~100)% WHO grade IV haematological toxicity was universal. 3 pts were hospltalised of feprlle neut]'oponia. There was no grade V t o , city. Objective response rate: 1 CR 1.6% (95%C1: 0-9.6%). 26 PR (42.7%. 95%C1: 31.1-55.2%). 23 SD (37.7%). 5 PD (8%). 5 NE (10%). 49 pts underwent restaging: 25 (51%. 95%C1: 37.5-64.5%) mediast]nal ddwnstaging. 22 (44.9%) persistent N2. 1 T4. 1 unknown. 27 pts proceeded to theracotomy: R0 resection 19. R1 2. biopsy only 6 patients. There were 3 pathological CR's. Adjuvant radiotherapy was administered to 26 pts. As per Jan. 200,5 median survival equals median ~llew up: 19+ (range 8+ -48+) months Twenty-seven patients are alive. 1g no evidence of cisease. 8. alive with disease 25 patients died of disease 5 26 me after initiation of tTeatment Conclusion: Efficacy of accelerated high dose epirubidn and cisplatln as indu~on chemotherapy for stage IIIAf)N2 NSCLC patients is not different from more commonly used cisplatln based regimen [ P ~ 7 ] Conourrent ¢hernoradlotherapy with ¢lsplatln and vlnorelblne In locally advanced non-small call lung cancer X. Sono. V. Gallant. S. Laurie. G. Nicholas. N. Reaumo. R. MacRae. O. Agboola. G. Perry. C. Lochrln. G. Gess. 7he Ottawa Rag/ona/Caner Centre, Ottawa, Canada

Background: Adding chemotherapy (CT) to raciotheragy (R]) improves survival in the b'eatment of locally advanced non small cell lung cancer (NSCLC). Concurrent chem oradiotharapy (CRT) appears supon or to sequential CRT. but there is no official consensus on what is the optimal chemotherapy regimen and timing of chemotherapy in relationship to RT At the Ottawa Regional Cancer CentTe (ORCC). dsplatin and vinorelbine has been the standard regimen used concurrently with RT ~r tTeatment of locally advanced NSCLC for several years We assessed tTeatment outcomes and toxicities using this particular regimen, and compared the outcomes to other concurrent CRT regimens reported in the literature (Furuse et al: Cho/ et al: Curran et al: I~erm ot al; Vokes ot al; Zatloukal ot al) Methods: A reb'espectlvo review of patients with stage III NSCLC b'eated with concurrent CRT between January 2000 and May 2004 at the ORCC was perlbrrnod. RT was prescribed at a dose of 6OGyi30 fraot]ons. CT consisted of up to six o/des of cisplatln (75~80mg/m 2) on day 1. and vinorelbino (25-30mg/m 2) on day 1 and day 8 for 21 days o/de. "Vlnorolbine dose was reduced to 12 5 l`5mg/m 2 dunng concurrent CR'I- Data extracted included patients demographics, dates of diagnosis, t]'eatmont, last follow up or death. t~iclty, and cisease status at last contact. Overall survival was calculated from the date of initiation oft]'eatment to date of death or last follow4Jp. Kaplan Meier estimates of overall survival (OS) and disease free survival (DFS) were plotted. Survival of patients who recalvod early RT (before cycle 2-3) was compared to late RT (after o / d e 2-3) using KaplanMeior with Iog4"ank statistics. Results: 82 patients (Stage IIIA/B 41.5%/58.5%) were b'eated with this protocol Median age was 63 years (3?" 80 years): 65% of patients were male ECOG performance status (PS) prior to tTeatment was 0/1 in 28%/72% of patients A median of 4 o/des of CT was administered (range1 6). and median RT dose was 60Gy (range 20 80Gy) Early/late RT was 36%/61% The patient characteristics receiving early RT were similar to those receiving late RT with respect to stage, age. and PS Median follow-up was 10 3 months (range 2 45months). median survival was 174 months (g`5%CI: 13 1 21 6 months). 1 and 2 years OS wore 58% and 40%. Median survival in these who received early RT was 10.2months and 20.2 months in those who recalvod late RT.. this difference was not statistically significant Co= 0.22). Median DFS was 11.8 months (95%C1:8.6-14.6 months). Overall response rate was 84% with 11% complete response. Only 7% of patients progressed on therapy and at