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A phase II study of Neoadjuvant Chemotherapy (NC) and Concomitant Chemoradiotherapy (CCRT) for stage II Non-Small Cell Lung Cancer (NSCLC)
163 608 UOXORUBICIN, W hypQJ~~Mctionnahi @&Sm&t?
PJ. Mdecine.
16 and
IFOSFAMIUE
innadiation
C&t b&~en
P. B &nue
04
[MI)
w.&?h
the
chebt
iSCLC): GLOT 86. de
ARISTOT. Fati&
Rocke&&h 06/89, 259
69008 p&&1&6
LYON FRANCE WIXLL .&c&&d
Fhom Ol/ll6 -to &I a mu.&%& piLoX b&u&j 6oh SCLC. 89 paL&ntb 134 %I appeaned to have eincited SCLC. Au patie_na uceived 4 cowrbe6 06 AYI (UXR 50 mg/mZ dl, W 16 150 mg/mZ dJ-2, IFM 2 g/m2 dl-21 evehy 3 weeba. Patim wti med tieaae [LV) ,+uu?hwc heceived ckebt .innadiation IRT) UJ.& W 16 and IFM be&een fithe 3 wwt6e6 06 UT depwu&d by 4 we&. RT
conbti&xl 06 5 days/week
1.1 Gy/&ztin, ioh tithe @bd
wti The
tieabe
2 6mtiWday, wwr~e and 1.5 Gy/&mti.on, 2 &utinb/day, 5 dayb/week ioh lhe beWIId and a%Ltd wuhbe doh a ZoaLx.%Z 04 51 Gy ; 2 couhbeb 06 AVI wae given in add&ion. Patient6 e&ens&e
neceived
JO wah6ed
06
AVI.
btiging and heb&gi.ng phoceduheb ix&&d &bibenopticbkOnChabWpy. The median 4ol.f~ up ib
42 months (20-63). The ove~.&!Z heaponbe tie a&en 3 wu~ed 06 AVI & 6%. 3 4 (24.1 % CR, 44.2 % PR), 6oh LD 73 % (39 0 CR, 34 % PR) . In LD adteh RT tie heponbe ib 62.9 0 (47.2 0 CR, 15.7 0 PR). Y~&ZII bWLViVd tie ib ove~.!X 10 months. doh LV 14, ED 9 monthb. Fob ElJ Xhe majoh .tOticicity ~a.4 hQmaaMog~&. Foh LD tie p&monahg &w&,&Q wti a~ 6ouaU [ 1 death 06 ac+e _pubnommy -totic.i@.
14 mod&e chronic lradcatcon totici..tq. Aeao encouhaging. tie 4ebukYb do noi appeixh ah good ab in phevioub pubeidhed b-im.&vt b.tud.ieb ubing a.uehnaxing chemohAdi.otithehapy.
A Phase If Study of Neoadjuvant Chemotbexapy (NC) and Conamdtant Chemoradiothera~y (CCBT) for Stage III Non-Snudl Cell Lung Cancer (NSCLC). W. Gradishw*, E. Vokes,P. Eoffman,C. English, M. Fequwa, J. Bitrq IX. Golomb. NorthweMem University* and University of Chicago, Chicago, Illinois, USA. Since 10188, 2.5 patients @ts) with stage III
NSCLC (14-I&ll-IHb) havebeen entered on a phaseIIstiyofNC,CCRT andsurgexy(for resectable disease). Fourteen fem&.aadllm&swere~tered witha meanageof59yeal.a (range 37-74). sixpts WithIHa disease underwent complete surgical resection prior toNC. NC consisted of3 cycles of
Mitomycin
(M), vinblastine (V) and cisplatin (I’) [MVPI as
deactibed. !k.vedeen pta are evslusble for response to MVP.
previously There was
1CR and 8 PR(5346). Fiveptsremained stable (SD)and3progreased (PD).None of the responding pts were resect& 1 refused, 2 bad table disease. medical contmindications,6hadpersisteat s~gicallyunrasec Grade. (G)3or4toxicity to MVP was common: G3 myelosoppreasion (My)-lop&G3or4 ototoxicity - 7pts,G3 nausea -2pts,G3 or4weight lo.ss-9pts,G2pulmonary (M) toxicity- lpt.Sixteenptshavecompleted CCRT consisting of continuous infusion 5-FU 800 mg/M*/day (d) x 5, hydroxyurea 1 gm po q 12 hour x 5 d, comb&d with 200 cGy photon irrPdiatioaIdxSeveryotberweelrtoatotaldoseof6000cGy. Three pte with P PR aflex MVP achieved P clinical CR after CCRT. Toxicity of CCRT was m&mtez G3 band-foot syndrome - 5 pts, G3 My - 10 pts, G3 mucaitis - 4 pts. The shady is closed to further accrual. Ten of 25 pts are alive (40%). Five pts are alive and disease tire. at 4,6,8,11 and 19 montbq 3/S pt.3 vae surgically rwected initially. We conclude that seqoeacing of NC and CCRT is feasible, however the toxicity is significant and the goal of downstaging pts into surgical candidates was not achieved with MVP.
SYNCHRONOUS RADIO-CHEMOTHERAPY @T-C) IN LOCALLY ADVANCED NON SMALL CELL LUNG CANCER (LANSCLC) C.Panoussaki$ D.V.Skarlos**,P.Pantelakos*, N.Zaboglou***,E.Samantas**,L.Vini**, N.Xarpassitis*, P.Papakostas** *Radiation Oncology Departement of "Agii Anargiri" Cancer Hospital **3d Departement of Oncology of "Agii Anargiri Cancer Hospital *** Universitst Dusseldorf From 1988-1990 56 pts median aged 64 (34-75) with previously untreated LANSCLC (31 pts 111% 25 pts IIIB), were treated with carboplatin 50 mg/m2 1.V for 5 consequtive days in the 1st and 5th week, Gesidine 3 mg/m2 1.V day 8,15,36 and RT 2Gy daily X 5 for 6 consequtive weeks (total 60Gy). 43 tumors were squamous-cell,3 large-cell and 10 adenocarcinoma.4 earlytumop related deaths were occurred; 12 pts achieved a CR (21,4%) and 18 a PR (32,1%). Median time to progression was 17 months for CR's and 8 for PR's. To date 35 pts have a renewed progression or relapse and 35 pts have died. The survival is 0,5-31 months (median 13). The study is ongoing.
PJ. Mdecine.
16 and
IFOSFAMIUE
innadiation
C&t b&~en
P. B &nue
04
[MI)
w.&?h
the
chebt
iSCLC): GLOT 86. de
ARISTOT. Fati&
Rocke&&h 06/89, 259
69008 p&&1&6
LYON FRANCE WIXLL .&c&&d
Fhom Ol/ll6 -to &I a mu.&%& piLoX b&u&j 6oh SCLC. 89 paL&ntb 134 %I appeaned to have eincited SCLC. Au patie_na uceived 4 cowrbe6 06 AYI (UXR 50 mg/mZ dl, W 16 150 mg/mZ dJ-2, IFM 2 g/m2 dl-21 evehy 3 weeba. Patim wti med tieaae [LV) ,+uu?hwc heceived ckebt .innadiation IRT) UJ.& W 16 and IFM be&een fithe 3 wwt6e6 06 UT depwu&d by 4 we&. RT
conbti&xl 06 5 days/week
1.1 Gy/&ztin, ioh tithe @bd
wti The
tieabe
2 6mtiWday, wwr~e and 1.5 Gy/&mti.on, 2 &utinb/day, 5 dayb/week ioh lhe beWIId and a%Ltd wuhbe doh a ZoaLx.%Z 04 51 Gy ; 2 couhbeb 06 AVI wae given in add&ion. Patient6 e&ens&e
neceived
JO wah6ed
06
AVI.
btiging and heb&gi.ng phoceduheb ix&&d &bibenopticbkOnChabWpy. The median 4ol.f~ up ib
42 months (20-63). The ove~.&!Z heaponbe tie a&en 3 wu~ed 06 AVI & 6%. 3 4 (24.1 % CR, 44.2 % PR), 6oh LD 73 % (39 0 CR, 34 % PR) . In LD adteh RT tie heponbe ib 62.9 0 (47.2 0 CR, 15.7 0 PR). Y~&ZII bWLViVd tie ib ove~.!X 10 months. doh LV 14, ED 9 monthb. Fob ElJ Xhe majoh .tOticicity ~a.4 hQmaaMog~&. Foh LD tie p&monahg &w&,&Q wti a~ 6ouaU [ 1 death 06 ac+e _pubnommy -totic.i@.
14 mod&e chronic lradcatcon totici..tq. Aeao encouhaging. tie 4ebukYb do noi appeixh ah good ab in phevioub pubeidhed b-im.&vt b.tud.ieb ubing a.uehnaxing chemohAdi.otithehapy.
A Phase If Study of Neoadjuvant Chemotbexapy (NC) and Conamdtant Chemoradiothera~y (CCBT) for Stage III Non-Snudl Cell Lung Cancer (NSCLC). W. Gradishw*, E. Vokes,P. Eoffman,C. English, M. Fequwa, J. Bitrq IX. Golomb. NorthweMem University* and University of Chicago, Chicago, Illinois, USA. Since 10188, 2.5 patients @ts) with stage III
NSCLC (14-I&ll-IHb) havebeen entered on a phaseIIstiyofNC,CCRT andsurgexy(for resectable disease). Fourteen fem&.aadllm&swere~tered witha meanageof59yeal.a (range 37-74). sixpts WithIHa disease underwent complete surgical resection prior toNC. NC consisted of3 cycles of
Mitomycin
(M), vinblastine (V) and cisplatin (I’) [MVPI as
deactibed. !k.vedeen pta are evslusble for response to MVP.
previously There was
1CR and 8 PR(5346). Fiveptsremained stable (SD)and3progreased (PD).None of the responding pts were resect& 1 refused, 2 bad table disease. medical contmindications,6hadpersisteat s~gicallyunrasec Grade. (G)3or4toxicity to MVP was common: G3 myelosoppreasion (My)-lop&G3or4 ototoxicity - 7pts,G3 nausea -2pts,G3 or4weight lo.ss-9pts,G2pulmonary (M) toxicity- lpt.Sixteenptshavecompleted CCRT consisting of continuous infusion 5-FU 800 mg/M*/day (d) x 5, hydroxyurea 1 gm po q 12 hour x 5 d, comb&d with 200 cGy photon irrPdiatioaIdxSeveryotberweelrtoatotaldoseof6000cGy. Three pte with P PR aflex MVP achieved P clinical CR after CCRT. Toxicity of CCRT was m&mtez G3 band-foot syndrome - 5 pts, G3 My - 10 pts, G3 mucaitis - 4 pts. The shady is closed to further accrual. Ten of 25 pts are alive (40%). Five pts are alive and disease tire. at 4,6,8,11 and 19 montbq 3/S pt.3 vae surgically rwected initially. We conclude that seqoeacing of NC and CCRT is feasible, however the toxicity is significant and the goal of downstaging pts into surgical candidates was not achieved with MVP.
SYNCHRONOUS RADIO-CHEMOTHERAPY @T-C) IN LOCALLY ADVANCED NON SMALL CELL LUNG CANCER (LANSCLC) C.Panoussaki$ D.V.Skarlos**,P.Pantelakos*, N.Zaboglou***,E.Samantas**,L.Vini**, N.Xarpassitis*, P.Papakostas** *Radiation Oncology Departement of "Agii Anargiri" Cancer Hospital **3d Departement of Oncology of "Agii Anargiri Cancer Hospital *** Universitst Dusseldorf From 1988-1990 56 pts median aged 64 (34-75) with previously untreated LANSCLC (31 pts 111% 25 pts IIIB), were treated with carboplatin 50 mg/m2 1.V for 5 consequtive days in the 1st and 5th week, Gesidine 3 mg/m2 1.V day 8,15,36 and RT 2Gy daily X 5 for 6 consequtive weeks (total 60Gy). 43 tumors were squamous-cell,3 large-cell and 10 adenocarcinoma.4 earlytumop related deaths were occurred; 12 pts achieved a CR (21,4%) and 18 a PR (32,1%). Median time to progression was 17 months for CR's and 8 for PR's. To date 35 pts have a renewed progression or relapse and 35 pts have died. The survival is 0,5-31 months (median 13). The study is ongoing.