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154 logic cell types were squamous 28, adeno- carcinoma 2 and large cell ll.2Treatment program was cispl~tin 60 mgm/m i.v. day i, 5-FU 800 mgm/m - i.v. over 24 hrs days 1-5 and simultaneous radiation therapy delivered to the primary tumor, media- stinum, and supraclavicular areas, 200 fads/day, days 1-5. Each cycle was repeat- ed every other week for 4 cycles. After a rest period of 4 weeks, patients were re- staged and subjected to thoracotomy. Of the original 50 patients, 33 were resected and 2 were technically non-re- sectable. Resections performed were pneu- monectomy 14, lobectomy 13, segmentectomy 4 and sleeve lobectomy 2. Operative mor- tality was 6% (2/33). The median survival of the patients ha- ving a thoracotomy is 16 months from the onset of treatment (4 days - 25 mos). Six- teen patients have recurred following re- section. However, ii patients are disease free with a median survival of 13 mos. (1-25 mos). Histologic staging following surgery revealed that 7 patients had no viable tumor in the resected specimen." The histo- logy in this group was squamous 4, adenocar- cinoma 2 and large cell i. Of these pa- tients, six remain disease free. These early results indicate that a com- bined program of preoperative chemothe- rapy and radiation is feasible and can be effective for clinical stage III NSCBC. Combined Modality Therapy For Regionally Advanced Stage Ill Non-Small Cell Carcinoma of the Lung (NSCCL) Employing Neo-Adjuvant Chemotherapy CCT) With Vindesine and Cis- platim~., Radiotherapy (RT) and Surgery CS>. Strauss, G., Sherman, D., Schwartz, J., Kadish, S., Liepman, M., Cederbaum, A., Carroll, G., Anastasia, L., Eilson, J., Vandersalm, T., Ward, A., Costanza, M. for the Central Massachusetts Oncology Group. Combined modality therapy employing CT, RT and S was used in selected patients with stage III NS~CL. CT consisted of vindesineg(3 mg/m- weekly) and cisplatinum (120 mg/m- every 3 weeks). Patients were stratified into two arms. Those who were marginally resectable were entered onto Arm A, and were treated with 2 cycles of CT, followed by 3000 rads RT, followed by S. Postoperatively, patients received 2500- 3000 rads RT, and 2-3 cycles of CT. Pa- tients who were categorically unresec- table were entered onto Arm B, and were treated with 2 cycles of CT, 5500-6000 rads of RT and 2-3 additional cycles of CT. 21 patients (14 males, 7 females) have been entered onto study (median age 53 yrs, range 37-67 yrs). 7 patients were entered onto Arm B. 2 had minor response to CT while 5 had early failure. All have died with a median survival of 5 months (range 1-8 months). 14 patients have been entered onto Arm A. TNM staging consist of T3NO-4, TIN2-4, T2N2-5, and TXN2-1. Median follow-up is ii months (range of 2-20 months). All 14 patients are evaluable for response to CT, and 13 are eva- luable to initial RT. Following CT, there were no CRs, 6 PRs (42%), 4 MRs (29%), and 4 NRs (29%); after CT and initial RT, there were 1 CR (8%), 9 PRs (69%), 2 MRs (15%), and 1 NR (8%). 9 patients have undergone thoracotomy and in 8 (88%), a complete tumor resection was achieved. Of the resected patients, 2 have died, 1 is alive with disease, and 6 are NED. Arm B has been closed, but based on these en- couraging preliminary results, Arm A will be expanded into a multi-institutional pilot study for Cancer and Leukemia Group B. Effectiveness of Adjuvant Chemotherapy in Ope- rable Non-Small Cell Lung Cancer (NSCLC). Ayoub, J., Duranceau, A., Lorange, G., Robi- doux, A., Pag4, A., Joassin, A., Delvecchio, P., Lemay, J., Paquin, F., Schurch, W., Henley, J., Simard, A., Cave, N. Le R4seau Interhospi- talier de Canc~rologie, Universit~ de Montreal (RICUM) Quebec, Canada. Sixty three eligible patients with ope- rable NSCLC were entered into a randomized study to determine the value of adjuvant che- motherapy (C.T.) following surgical resection. All patients had intraoperative staging with careful lymph node mapping. Patients without lymph node (LN) invasion were randomized into regimen A: surgical resection or regimen B: resection followed by C.T. Patients with LN invasion were randomized into regimen C: re- section followed by radiotherapy or regimen D: resection followed by 2 cycles C.T., radio- therapy and then 4 other C.T. 9ycles. C.T. consists of vindesine 2 mgms/m- i.v. weekly every for 6 months for 5 weeks and then ~ weeks plus cis-platinol 60 mgms/m i.v. every 4 weeks for 6 cycles. In 31 patients with LN invasion 6 recur- rences occurred (median follow up 9 months). 5 recurrences occurred in 16 patients who received only local treatment, compared to one in 15 patients who received local and syste- mic treatment. In that group, vascular inva- sion was present in 7 patients. So far, 6/7 are disease-free for a median duration of 6 months. It appears from this preliminary ana- lysis that the addition of systemic therapy is effective in diminishing the number of re- currences. Further accrual and follow-up will be necessary to determine if this difference in the number of recurrences will lead to a difference in overall recurrence rates and survival and to study as well the prognostic significance of vascular invasion. Supported by Eli Lilly Canada Inc.

Combined modality therapy for regionally advanced stage III non-small cell carcinoma of the lung (NSCCL) employing neo-adjuvant chemotherapy (CT) with vindesine and cisplatinum, radiotherapy

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154

logic cell types were squamous 28, adeno- carcinoma 2 and large cell ll.2Treatment program was cispl~tin 60 mgm/m i.v. day i, 5-FU 800 mgm/m - i.v. over 24 hrs days 1-5 and simultaneous radiation therapy delivered to the primary tumor, media- stinum, and supraclavicular areas, 200 fads/day, days 1-5. Each cycle was repeat- ed every other week for 4 cycles. After a rest period of 4 weeks, patients were re- staged and subjected to thoracotomy.

Of the original 50 patients, 33 were resected and 2 were technically non-re- sectable. Resections performed were pneu- monectomy 14, lobectomy 13, segmentectomy 4 and sleeve lobectomy 2. Operative mor- tality was 6% (2/33).

The median survival of the patients ha- ving a thoracotomy is 16 months from the onset of treatment (4 days - 25 mos). Six- teen patients have recurred following re- section. However, ii patients are disease free with a median survival of 13 mos. (1-25 mos).

Histologic staging following surgery revealed that 7 patients had no viable tumor in the resected specimen." The histo- logy in this group was squamous 4, adenocar- cinoma 2 and large cell i. Of these pa- tients, six remain disease free.

These early results indicate that a com- bined program of preoperative chemothe- rapy and radiation is feasible and can be effective for clinical stage III NSCBC.

Combined Modality Therapy For Regionally Advanced Stage Ill Non-Small Cell Carcinoma of the Lung (NSCCL) Employing Neo-Adjuvant Chemotherapy CCT) With Vindesine and Cis- platim~., Radiotherapy (RT) and Surgery CS>. Strauss, G., Sherman, D., Schwartz, J., Kadish, S., Liepman, M., Cederbaum, A., Carroll, G., Anastasia, L., Eilson, J., Vandersalm, T., Ward, A., Costanza, M. for the Central Massachusetts Oncology Group.

Combined modality therapy employing CT, RT and S was used in selected patients with stage III NS~CL. CT consisted of vindesineg(3 mg/m- weekly) and cisplatinum (120 mg/m- every 3 weeks). Patients were stratified into two arms. Those who were marginally resectable were entered onto Arm A, and were treated with 2 cycles of CT, followed by 3000 rads RT, followed by S. Postoperatively, patients received 2500- 3000 rads RT, and 2-3 cycles of CT. Pa- tients who were categorically unresec- table were entered onto Arm B, and were treated with 2 cycles of CT, 5500-6000 rads of RT and 2-3 additional cycles of CT.

21 patients (14 males, 7 females) have been entered onto study (median age 53 yrs,

range 37-67 yrs). 7 patients were entered

onto Arm B. 2 had minor response to CT while 5 had early failure. All have died with a median survival of 5 months (range 1-8 months). 14 patients have been entered onto Arm A. TNM staging consist of T3NO-4, TIN2-4, T2N2-5, and TXN2-1. Median follow-up is ii months (range of 2-20 months). All 14 patients are evaluable for response to CT, and 13 are eva- luable to initial RT. Following CT, there were no CRs, 6 PRs (42%), 4 MRs (29%), and 4 NRs (29%); after CT and initial RT, there were 1 CR (8%), 9 PRs (69%), 2 MRs (15%), and 1 NR (8%). 9 patients have undergone thoracotomy and in 8 (88%), a complete tumor resection was achieved. Of the resected patients, 2 have died, 1 is alive with disease, and 6 are NED. Arm B has been closed, but based on these en- couraging preliminary results, Arm A will be expanded into a multi-institutional pilot study for Cancer and Leukemia Group B.

Effectiveness of Adjuvant Chemotherapy in Ope- rable Non-Small Cell Lung Cancer (NSCLC). Ayoub, J., Duranceau, A., Lorange, G., Robi- doux, A., Pag4, A., Joassin, A., Delvecchio, P., Lemay, J., Paquin, F., Schurch, W., Henley, J., Simard, A., Cave, N. Le R4seau Interhospi- talier de Canc~rologie, Universit~ de Montreal (RICUM) Quebec, Canada.

Sixty three eligible patients with ope- rable NSCLC were entered into a randomized study to determine the value of adjuvant che- motherapy (C.T.) following surgical resection. All patients had intraoperative staging with careful lymph node mapping. Patients without lymph node (LN) invasion were randomized into regimen A: surgical resection or regimen B: resection followed by C.T. Patients with LN invasion were randomized into regimen C: re- section followed by radiotherapy or regimen D: resection followed by 2 cycles C.T., radio- therapy and then 4 other C.T. 9ycles. C.T. consists of vindesine 2 mgms/m- i.v. weekly

every for 6 months for 5 weeks and then ~ weeks plus cis-platinol 60 mgms/m i.v. every 4 weeks for 6 cycles.

In 31 patients with LN invasion 6 recur- rences occurred (median follow up 9 months). 5 recurrences occurred in 16 patients who received only local treatment, compared to one in 15 patients who received local and syste- mic treatment. In that group, vascular inva- sion was present in 7 patients. So far, 6/7 are disease-free for a median duration of 6 months. It appears from this preliminary ana- lysis that the addition of systemic therapy is effective in diminishing the number of re- currences. Further accrual and follow-up will be necessary to determine if this difference in the number of recurrences will lead to a difference in overall recurrence rates and survival and to study as well the prognostic significance of vascular invasion.

Supported by Eli Lilly Canada Inc.