Phase II study of high dose ifosfamide plus mesna in inoperable non small cell lung carcinoma

Clinical Trials Summaries

Phase

II Study of High Dose Ifosfamide

Mesna

in Inoperable

Non Small

Plus

Cell Lung

Carcinoma ZULAY

PASTR,4N,

THIERRY

LE CHEVALIER, PIERRE ARRIAGADA,

BALDEYROU, JE,4N-PIERRE

Comite’ dc Pathologic

IFosFAhnnE analog

of

reported small

an

cell lung high

by more mesna

alkylating

which

a 32-39% carcinoma

degree

Table

oxazaphosphorinc

cyclophosphamide

to give

This

doses

is

rcsponsc (NSCLC)

of activity

has rate

Institut GutnaP-Rouq,

RODRIGO ROUESSE Ci’llpjuiJ France

I. Patient charactuiatic-c

been

[ 1, 21.

was

not confirmed

recent

studies

[3], but

the adjunction

bladder

toxicity

led us to test high

looking

SPIELMANN, and JllCQUES

in non

avoiding

of Ifosfamidc

thoracique,

MARC DROZ

for a dose

effect

of [4].

I2 II

MATERIALS Between with

April

inoperable

mesna

NSCLC

as first

Eligibility

mm”,

strum

med

consent.

shown

lint

1986, 30 patients

received

included

creatinine

pcrformancc

plus

3 27

status

50%) objectively count > 2000/

< 120 pmol/l

Characteristics

in Table

Ifosfamide treatment.

scale) greater than disease, granulocytc

All patients on

METHODS

chemotherapy

criteria

(Karnofsky measurable

AND

1985 and July

and

of the

patients

inforarc

1. rcccived

2 consecutive

days

4 g/m’/day with

of Ifosfamide

mesna

48 h every 4 weeks. Ifosfamide was 2000 ml of 5% dextrose saline solution istered

as an i.v.

infusion

mesna

was

as 24 h continuous

given

Response and toxicity to the WHO scale [5].

Accepted 21 ,January Correspondence and Comiti de Pathologic Camille Desmoulins,

over were

8 g/m2

12 h by day

cvaluatcd

over

dissolved in and adminand

infusion. according

RESULTS Of the 30 patients, five received one cycle, nine received two cycles and 16 more than two cycles.

1988. rrquests for reprints to: ‘1‘. 1~ Chcvalicr, thoraciquc, Institut Gustave-Roussy. Rue 94800 Villejuif, France.

Partial response cnts (10% with 1073

EJC 24:6-I

(PR) was achieved a 95% confidcncc

in three patiinterval of

Clinical

1074 2-27%).

No

(43%)

and

change

Of the three cell carcinoma All of them inclusion. ively change IV

had

Time Mean group

disseminated to tumor

8 months time was

despite

in 13 patients

patjents,

one squamous

two had

disease

Hcmatological toxicity was seen in two patients (Grade IV in one) and CNS toxicity occurred in

large

at time

progression

patient.

of

(range

responding

CONCLUSION

in

the

The no

2-6).

in all patients (4 Grade and vomiting in 60% of

prophylactic

one

was respect-

for the three to

Summaries

cell carcinoma.

progression

3.6 months

Alopecia was observed and 26 Grade III)

patients

observed

in 14 patients.

responding and

2, 3 and

patients.

was

progression

Trials

treatment.

was

tolerance acceptable

of a 8 g/m2 in

visceral toxicity but rate was disappointing incorporate rcgimcns

Ifosfamide

terms the

of

schedule

and

10% objective response and did not incite us to

in combined

chemotherapy

for NSCLC.

REFERENCES 1. Morgan

LR, Posey LE; Rainey J et al. Ifosfamide: a weekly dose fractionated schedule in bronchogenic carcinoma. Cancer Treat Rep 1981, 65, 693-695. 2. Costanzi JJ, Gaglian R, Loukas D et al. Ifosfamide in recurrent or disseminated lung cancer. Cancer 1978, 41, 1715-1719. 3. Loehrer PJ, Birch R, Kramer BS et al. Ifosfamide plus N-acetylcysteine in the treatment of small cell and non small cell carcinoma of the lung. Cancer Treat Rep 1986, 70, 919-920. effects of single-push 4. Klein HO, Dias Wickramanayake P, Cristian E et al. Therapeutic of fractionated injections or continuous infusion of oxazaphosphorines. 1193-1203. 5. World Health Organization. WHO Handbook for Reporting the Results Geneva, WHO Offset Publication No. 48, 1979.

on 2 days

hcmatological

Cancer of Cancer

1984,

54,

Treatment.