“wait & see” in asymptomatic non-operable non-small cell lung cancer (nsclc), an important...

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171 could be detected between patients with stage I or II disease or between patients who had achived a CR or a PR with chemo- therapy. The survival of these 20 patients was also not significantly longer than that of 33 stage I patients treated only with CAV and radiotherapy. The true role of ad- juvant SR in SCLC awaits prospective rando- mized trials. Pulmonary Toxicity (PT) With Combined Moda- lity Therapy for Limited Stage Small Cell Lung Cancer (SCLC). Ihde, D., Brooks, B., Seifter, E., Walsh, T., Zabell, A., Johnston-Early, A., Makuch, R., Edison, M., Bunn, P., Lichter, A., Co- hen, M., Glatstein, E. NCI-Navy Med. and Rad. Oncol. Brs., Natl. Cancer Inst. and Naval Hosp., and VA Med. Cent., Bethesda, MD 20814 and Washington DC 20422, U.S.A. In a prospective randomized study in limited SCLC, 40 patients received combi- nation chemotherapy (CT) alone and. 40 were given CT + radiation therapy (RT) (4000 rads/15 fractions/initial 3 weeks concur- rent with CT). We noted 13 cases of life- threatening PT, defined as bilateral pul- monary infiltrates extending beyond radi- ation ports and requiring hospital admis- sion. PT occurred in ii patients (28%) on CT + RT and in 2 (5%) on CT alone (p<0.02). Seven patients died from PT with no clini- cal evidence of tumor in 6. PT initially presented at a median of 63 days (range 21- 150) after start of CT + RT and at a median of 217 days after CT alone. Biopsies ob- tained in l0 patients revealed interstitial fibrosis with no evidence of an infectious agent. Review of pretreatment parameters such as age, prior pulmonary disease, per- formance status, and radiation field size failed to reveal any significant differen- ces between patients with or without PT. However, initial pulmonary function tests (PFTs) revealed significantly lower vital capacity (p=0.03) and forced expiratory volume/l.0 second (p=0.04) in patients with subsequent PT. PT was significantly more common with combined modality therapy than with CT alone and worse than expected with RT alone. Furthermore, PFTs prior to the- rapy may identify patients at risk for PT. Despite the increased incidence of PT in the CT + RT group, overall survival was not significantly different in the 2 groups, but a clear trend favored the combined moda- lity arm. Enhanced local control and dis- ease-free survival appeared to compensate for the initial increased pulmonary morbi- dity and mortality in the CT + RT group. i0, OTHER TREATMENT MODALITIES "Wait & See" in Asymptomatic Non-Operable Non-Small Cell Lung Cancer (NSCLC), an Im- portant Question? van Zandwijk, N., Dalesio, O., Kirkpatrick, A., McVie, J.G. for the EORTC Lung Cancer Co- operative Group. We studied the reasons behind the lack of accrual of patients (pts) in a multicenter tri- al comparing immediate versus delayed radio- therapy in asymptomatic non-operable NSCLC patients sponsored by the EORTC Lung Cancer Cooperative Group. Although estimation on the basis of a lite- rature survey, clinical experience and a pre- trial enquiry indicated that the Group would accrue enough patients within two years to an- swer the question whether immediate treatment is superior to "wait and see" in terms of sur- vival or quality of life, in the first year of the study only 7 pts were randomized. A que- stionnaire followed by prospective registrati- on of all NSCLC pts seen in i0 institutions during 9 months, revealed that only 25 out of 504 pts met the eligibility criteria. This is far fewer than predicted and is explained by a significant proportion of patients present- ing with i. extensive disease (39%), 2. and/ or major symptoms (27%). Of the small group of patients who met the eligibility criteria the majority of patients refused to be rando- mized. 70% of the doctors reported that the procedure of "informed consent" prior to rando- mization made the trial impossible. Thought should be given in future trials to "post ran- domization informed consent". Long Term Results of Injection of Autologous Tumour Cells and Percutaneous BCG into Patients Undergoing Resection of Lung Cancer. Stack, B.H.R., Hole, D.J., Spilg. W.G.S. West of Scotland Lung Cancer Group. In an attempt to stimulate postooperative cell-mediated immunity to residual tumour cells, autologous tumour cells and adjuvant percuta- neous BCG were injected into patients under- going resection of lung cancer. Eighty-three patients were given one single percutaneous multiple puncture treatment with BCG Glaxo one week before operation. At the time of operation, patients were randomly allo- cated to the autograft (39) or control (44) groups. The autograft group patients received serial injections of irradiated autologous tumour cells and percutaneous BCG during 3 weeks after operation. All patients were revi- wed at regular intervals for 5 years and on one further occasion in 1984. Five years after operation the percentage of patients surviving were 36% (autograft) and 32% (control), difference not significant (NS). The median survival times for each group were 27 (autograft) and 14 (control) months, (NS). The 5 year survival percentage for DNCB posi- tive patients were 69% (autograft, n = 17) and 25% (control, n = 17) and their median survival times were > 60 months and 12 months (p = o.o4). Postoperative injection of autologous tumour

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could be detected between patients with stage I or II disease or between patients who had achived a CR or a PR with chemo-

therapy. The survival of these 20 patients was also not significantly longer than that of 33 stage I patients treated only with CAV and radiotherapy. The true role of ad- juvant SR in SCLC awaits prospective rando- mized trials.

Pulmonary Toxicity (PT) With Combined Moda- lity Therapy for Limited Stage Small Cell Lung Cancer (SCLC). Ihde, D., Brooks, B., Seifter, E., Walsh, T., Zabell, A., Johnston-Early, A., Makuch,

R., Edison, M., Bunn, P., Lichter, A., Co- hen, M., Glatstein, E. NCI-Navy Med. and Rad. Oncol. Brs., Natl. Cancer Inst. and Naval Hosp., and VA Med. Cent., Bethesda, MD 20814 and Washington DC 20422, U.S.A.

In a prospective randomized study in limited SCLC, 40 patients received combi- nation chemotherapy (CT) alone and. 40 were given CT + radiation therapy (RT) (4000 rads/15 fractions/initial 3 weeks concur- rent with CT). We noted 13 cases of life- threatening PT, defined as bilateral pul- monary infiltrates extending beyond radi- ation ports and requiring hospital admis- sion. PT occurred in ii patients (28%) on CT + RT and in 2 (5%) on CT alone (p<0.02). Seven patients died from PT with no clini- cal evidence of tumor in 6. PT initially presented at a median of 63 days (range 21- 150) after start of CT + RT and at a median of 217 days after CT alone. Biopsies ob- tained in l0 patients revealed interstitial fibrosis with no evidence of an infectious agent. Review of pretreatment parameters such as age, prior pulmonary disease, per- formance status, and radiation field size failed to reveal any significant differen- ces between patients with or without PT. However, initial pulmonary function tests (PFTs) revealed significantly lower vital capacity (p=0.03) and forced expiratory volume/l.0 second (p=0.04) in patients with subsequent PT. PT was significantly more common with combined modality therapy than with CT alone and worse than expected with RT alone. Furthermore, PFTs prior to the- rapy may identify patients at risk for PT. Despite the increased incidence of PT in the CT + RT group, overall survival was not significantly different in the 2 groups, but a clear trend favored the combined moda- lity arm. Enhanced local control and dis- ease-free survival appeared to compensate for the initial increased pulmonary morbi- dity and mortality in the CT + RT group.

i0, OTHER TREATMENT MODALITIES

"Wait & See" in Asymptomatic Non-Operable Non-Small Cell Lung Cancer (NSCLC), an Im-

portant Question? van Zandwijk, N., Dalesio, O., Kirkpatrick,

A., McVie, J.G. for the EORTC Lung Cancer Co- operative Group.

We studied the reasons behind the lack of accrual of patients (pts) in a multicenter tri- al comparing immediate versus delayed radio- therapy in asymptomatic non-operable NSCLC patients sponsored by the EORTC Lung Cancer Cooperative Group.

Although estimation on the basis of a lite- rature survey, clinical experience and a pre- trial enquiry indicated that the Group would accrue enough patients within two years to an- swer the question whether immediate treatment is superior to "wait and see" in terms of sur- vival or quality of life, in the first year of the study only 7 pts were randomized. A que- stionnaire followed by prospective registrati- on of all NSCLC pts seen in i0 institutions during 9 months, revealed that only 25 out of 504 pts met the eligibility criteria. This is far fewer than predicted and is explained by a significant proportion of patients present- ing with i. extensive disease (39%), 2. and/ or major symptoms (27%). Of the small group of patients who met the eligibility criteria the majority of patients refused to be rando- mized. 70% of the doctors reported that the procedure of "informed consent" prior to rando- mization made the trial impossible. Thought should be given in future trials to "post ran- domization informed consent".

Long Term Results of Injection of Autologous Tumour Cells and Percutaneous BCG into Patients Undergoing Resection of Lung Cancer. Stack, B.H.R., Hole, D.J., Spilg. W.G.S. West of Scotland Lung Cancer Group.

In an attempt to stimulate postooperative cell-mediated immunity to residual tumour cells, autologous tumour cells and adjuvant percuta- neous BCG were injected into patients under- going resection of lung cancer.

Eighty-three patients were given one single percutaneous multiple puncture treatment with BCG Glaxo one week before operation. At the time of operation, patients were randomly allo- cated to the autograft (39) or control (44) groups. The autograft group patients received serial injections of irradiated autologous tumour cells and percutaneous BCG during 3 weeks after operation. All patients were revi- wed at regular intervals for 5 years and on one further occasion in 1984.

Five years after operation the percentage of patients surviving were 36% (autograft) and 32% (control), difference not significant (NS). The median survival times for each group were 27 (autograft) and 14 (control) months, (NS). The 5 year survival percentage for DNCB posi- tive patients were 69% (autograft, n = 17) and 25% (control, n = 17) and their median survival times were > 60 months and 12 months

(p = o.o4). Postoperative injection of autologous tumour