combined modality therapy for regionally advanced stage iii non-small cell carcinoma of the lung...

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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.

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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.