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CONCBNTRATION OF SERUM GRANULOCYTE COLONY- STIMULATING FACTOR (SO-CSF) MJRINO CHEMOTIIERAPY- INDUCED GF#zNULCCYTOPENIA IN LUNG CANCER PATIENTS ASSAYED BY CABMILUMINBSCENCE ENZYME IMMUNOASSAY (CLEIA). S. Hashimoto, T. Takeuchi, A. Yoshii, Y. Fukuda,

N. Ohsawa, First Department of Internal Medicine, Osaka' Medical College, Osaka, Japan

The recent development of CLEIA, a highly sensitive assay for sG-CSF (R.Kiriyama et al. Clinica. Chimica. Acta. in press), has made it possible to assay the sG-CSF concentration(Gc) in healthy individuals and to follow up the GC during the period of chemotherapy(Cx)-induced granulo- cytopenia. We used the system to assay the Gc in seven lung cancer patients treated with CDDP 80 mq/m '(day 1) and VDS 3mq/m '(day 1 and day 8). Before and after Cx, the blood cell count and sG-CSF assay were performed.

Results: The Cx suppressed the median neutro- phi1 counts(Nc) from 5482/pl(ranqe 2452 to 9024) to 944/pl(ranqe 419 to 1380) at nadir (~~0.01). The median Gc increased from 9.0 pg/ml (range 7.0 to 24.0) to 58.0 pq/ml(range 11.0 to 1200.0) (P<O.Ol). There was a reverse correlation between the sG-CSF increment ratio(Gc after Cx / Gc before Cx) and the neutrophil decrement ratio(Nc after Cx / NC before Cx) (r=0.589), but there was wide variation in the peak Gc among the patients. The Gc increased approximately 3 days before nadir of neutrophil. These data indicate that Gc monitoring is useful in modifying the timing and dosage of G-CSF administration against &-induced qranulo- cytopenia.

330

KARNOFSKYANDECOGPERFORMANCESTATUSIN~G CANCER: EQUWALENCE, CONSI'RUCT VALIDITY, AND PREDICTIVEVALIDITY. Giantimco Buccheri, aOlrpaic0 W&no The A. Carle Hospital of Chest Diseases, Cuoeo, Italy.

Bwkgmmd. The Kmofsky (KPS) and the Eurtem cooperptive oncology Group pr&mnance slalw (ECOG-PS) am the mosl widely used method8 of asswing the funclioMl *hIa of canc8r p&n@. blti8lUdyWeiOtEZUkdt0 compuc~v~i~ofthetwo~,ladtoprovidea~~~hble beweeo KPS and ECffi-PS. M&o&. 471 lung - (LC) p&m were assigmd both KPS and ECOG wzore~ by one phye.ician (in all, 1105 psaignmenb). bIthatoccasioa,avIuietyofdmlogmpbic,clinialMd laborstory data. aIonS wiul the patient asawmnen tofhismvnfunctionalshbls, wnslewrded. Readt.5. KPSMdlxxx-PS&gnmul~wem~mlaied to each other (Sparmsn r= -0.72, no.1105, p=O.C000). c!oMbWtvalidilyof both scales WUI confumed by the sigeifiuet correlation with the pltient rated scak (KPS Sr=-O.54, and ECCGPS=O.60, w.=602, P=O.oooO). Both KPS and ECOG-PS were related to many clinical variabh (Sr coefficients &we 0.2 for weight loss, hem&bin, white cell and pInkIeI count, LDH. ESR, TPA, T,N, and M-factors, stage. of disease). However, KPS was bet&r predicted by I& above factors (adjusted R2=0.20 vs 0.16, no.=800, p=O.OJOO. multiple mgnxsion analysis). The rel&msldp of KPS and, more, ECOGPS to lollgevity (Mantel-CQX st&tic=47.25 VB 65.79, p=O.OOOO) docmnated their predictive capabiity. ECOG-PS, but not KPS, was selected PB P powerful prognostic cofactor in a C&s huards mggression model wntairdag both performance scores and other 18 possible prognostic factors. Fiealty, the best calversion model was: lOO=o: s&90=1; 6c-70=2; 4mO=3; md 30 or Icm=4. Using this able of equivalence, 871 of 1105 KPS scmwi.e.79%, wm cmcctiy tmsformed ia ECGG scorw; lhe convemiaa was more succesafid for KPS axwee comprised batweo 90 and 60, with 85% hits. Condmbn. KPS and ECOG-PS scnles are both valid, but the sseoad irlstrmnedlt - superior and should be preferred. Ifnecessuy,dleycsnamvertedtoeacllotburwitb sufficient accumcy.

CUNICAL EFFECTS OF HIGH-DOSE MEDROXYPROGESTERONE ACETATE (YPA) IN ANOREXIC PATIENTS WITH ADVANCED LUNG CANCER (LC) Gianrianco Bucchati, Domanico FemQno Departments of Pulmonary Medicine, A. Carte Hospital, Cuneo, Italy.

Background. Cachexia affects as many as 87% of patients with advanced maliinant diseases. Cachexia produces an aver-incmaslnp spiral of anorexia, undernutrition, loss of body mass, muscle wasting, and increased susceotibilitv to infection and treatment toxicitv. Suwestions from the literat& indi&ate that pmgestins may be useful ior aileiT&tion of disease-associated appetite end weigM loss, even in patients with hormone insensitive tumors. This pli&e II study aimed to assess the clinical effect of the chronic administration of MPA in anorexic oatienta with an advanced LC. Methods. 47 consenting patients, with an advanoed LC and poor nutritional status, received MPA loo0 mg orally u.i.d., for a minimum of 3 weeks of treatment. Other treatments (Le., chemotherapy or radiation therapy) were continued as planned. 34 oatienta mainteined a stable disease status durino the MPA studv and km evaluable. Parameters reaxded tire and abler-*MPA administration wire: performance status (both ECOG-PS and KPS scales), body weight. midan circumference (MAC), triceps skinfold thickness (TST), routine lab tests, total pmtelns. albumin, prealbumin, and tranafentn serum levels. doctor- and patient-rated symptoms, physical well-being, and psychosocial status. Statistical comparisons were performed using the Wilcoxon signed rank test and the paired t’ test, as appropriate. Resutte. Mean body weigM was 58.84 kg before and 80.03 afler MPA (p=O.M), while mean TST was 5.88 mm before and 8.53 after MPA (p=O.OS). No other wmpatiaon was statistically significant. Conclusion. Although medroxypmgesterone acetate cannot be expected to directly affect the prognosis of patients with lung cancer, these data seams to confhm that MPA may reverse the eplral of cancer anorexia and cachexia. improve nuhttional status, and, ultimately, increase host resistance.

331

QUALITY OF LIFE (QL) ASSESSMENTS IN PATIENTS WITH NSCIC TREATED ON NAVELBINE CLINICAL TRJALS. C. Moinpour, G. Donaldson, P. McSorley, L Bert&, and J. Hohoeker. SWOG Statistical Center, Seattle, WA, Pain Research Group, FHCRC, Seattle, WA, Burroughs Wellcome Co., RTP, NC NAVELBlNE (NVB) is B unique semi-synthetic vinca alkaloid that has demonstrated activity in lung and breast cancer. While improved survival is the desired outcome of treatment with oncologic agents, the quality of survival, especially palliation of symptoms, is also important Patient-generated QL assessment was included as an important efficacy parameter in 2 clinical trials in NSCLC: a 2-arm randomized (2: 1) trial (reported by O’Rourke et al, Pmc ASCO 1993) comparing IV NVB (30 me/m2/wk) with 5-Fluorouracil(425 mg/m2/q 4 wk) plus Leucovorin (20 mplm2/q 4 wk) (S-FU/L) and an uncontrolled trial (repfled by Vokes et al; Proc ASCO 1993) of oral NVB given weekly. The QL instrument used in these clinical trials was adapted l+om the SWOG QL questionnaire. The domains that were assessed included role functioning, physical functioning, symptom distress and global QL. QL assessments were completed q2wks for 8 weeks the q4wks x 2. In the randomized study, 143 patients were treated with NVB and 68 with 5-FIX. Compliance was good with minimal intervening missing data. However, many patients discontinued study before completion of the required number of questionnaires, primarily due to disease progression: 25% of the S-RI/L and 44% ofthe NVB patients completed questionnaires beyond 8 weeks. Therefore, the remaining 5-FUiL patients were “healthier” than the remaining NVB patients. Despite this selectivity bias, examination of the rate of change in symptom dis!ress across 16 weeks favored patients receiving NVB. No differences were noted between the 2 groups in physical functioning, role tictioning or global QL. In the uncontolled shldy, again, (57% of patients were discontinued from the study before 8 weeks) 43% of patients completed QL questionnaires beyond eight weeks. Although there was no comparison arm. scores for each domain were consistent with scores on the randomized trial. In conclusion, in the randomized trial, there appears to lx less symptom deterioradon for patients treated with NVB compared to those treated with 5- FU/L for advanced NSCLC.