25 Survey on the treatment of non-small cell lung cancer (NSCLC) in England and Wales
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9 CT group. Except for hair loss, no QOL domain differences were seen in favour of the BSC group. Median survival times were 29 weeks (CT) vs. 11 weeks (BSC). l-year survival rates were 28% (CT) vs. 8% (BSC). QOL measurements and survival curves ware similar in the randomized and non-randomized patients receiving CT. Conclusion: Treatment with carboplatin and etoposide can improve both the quality of life and survival of patients with advanced NSCLC. crl 23 Chemotherapy for advanced non-small lung cancer (NSCLC) is only marginally effective: Can we afford it? cl 25’ Survey on the treatment of non-small cell lung cancer (NSCLC) in England and Wales Fergus Macbeth. Llandough Hospital, Penarth, South Glamorgan Wales, A. Crook, A. Duffy, D.J. Girling, R.L. Souhami, M.K.B. Parmar. MRCCanc. UK Trials Off, Cambridge; Middlesex Hosp., Lon., UK Currently available cisplatin-based chemotherapy regimens are effective in prolonging survival for patients with advanced NSCLC. but the benefit is only modest in terms of survival and still uncertain in terms of quality of life. At present only a small minority of these patients in the UK receive chemotherapy. As an adjunct to a meta-analysis comparing primary treatment + chemotherapy (CT) for NSCLC (NSCLC Collaborative Group. BMJ 1995; 311: 899-909) we conducted a survey in England and Wales to discover clinicians’ views on the role of CT in NSCLC and on what benefits from it would lead them to change their practice. The Beatson Oncology Centre provides almost all the non-surgical oncology services to a population of 2.8 million in the West of Scotland with a budget of about f15 million. In this population there are 3,000 new cases of lung cancer, of which about 75% are NSCLC. If 50% of these patients were now to be treated with 4 courses of cisplatin-based chemotherapy, the total cost would be about 22.6 million, a more than 15% increase in spending. These costs would probably double if taxanes were used. This amount of money is not currently available in the health-care system and would not be ‘liberated by savings in other sectors. Finally, there is no strong pressure either from the public or from the medical profession to provide this additional service. Specialists in radiotherapy (RT), oncology, thoracic surgery, and tho- racic and palliative medicine were asked their views on the treatment of 3 case histories of 65-year-old men: case I, resected tumour involving a hilar node (T2, Nl, MO); case 2, tumour that had spread to mediastinal nodes bilaterally (T2, N3, MO): and case 3, metastatic cancer (Ml) accompanied by minor haemoptysis. The acceptability of any medical procedure in a particular society at a particular time depends on a balance of three factors: SCIENCE (ef- fectiveness), ECONOMICS (cost and budgetary constraints), CULTURE (public and medical opinion). Chemotherapy for NSCLC is not regarded as a priority in the Scotland at present, and this view will only change when there is a significant change in any of the three factors above. 698 (85%) of the 821 clinicians responded. For case I, 74% would not recommend any adjuvant treatment, 24% would recommend RT, and <I% CT, and there was little expectation that adjuvant treatment would improve survival. For case 2,88% would recommend RT, 11% CT, and 1% surgery, 7% recommending a combination. More than 85% expected 5% or less survival beyond 5 years or median survival of 12 months or less. Adjuvant treatment, regardless of modality, was expected to improve survival. For case 3, only 11% would recommend CT, but 26% if the patient was aged 50 years or less. There was little expectation of survival beyond 1 year, or of improving it with CT. For all 3 cases, most clinicians not recommending CT would require it to achieve substantially improved survival for them to use it routinely. Radiotherapists were less likely than other clinicians to recommend CT. El 24 Phase Ill study of gemcitabine (Gemzar@) versus best supportive care (BSC) in advanced non-small cell lung cancer (NSCLC)’ H. Anderson ‘, B. Cottiers, M. Nicolson 3, R. Milroy 4, T. Maughan 5, M. Bond 6, S. Falk’, P. Burt 8, J. Carmichael g, N. Thatcher’ on behalf of the Gemcitabine Study Group. ’ Wythenshawe Hosp., Manchester; 2 Clatterbridge Hosp. Merseyside; 3Aberdeen Royal Infirm., Aberdeen; 4Stobhi// NHS Trust, Glasgow; 5 Velindre Hosp., South Glamorgan; 6 Cookridge Hosp., Leeds; 7 United Bristol Healthcare NHS Trust, Bristol; *Christie Hosp., Manchester; gNoffingham City Hosp., Nottingham, UK Gemcitabine (GEM) has shown a reproducible 20% response rate in NSCLC phase II trials. This UK study of GEM versus BSC enrolled 300 symptomatic pts in 26 centres between December 1994 and April 1996. One pt. withdrew consent shortly after being enrolled. GEM 1000 ms/ms was administered on days 1, 8, 15 of a 28 day schedule. This interim analysis was performed in June 1996. The two arms were well balanced with regard to stage, PS and demographics. GEM (N = 150) WC (N = 149) FWlales Age: median (range) KPS: 60-70 80-90 Squamous Adenocarcinoma Stage IV Disease 34% 39% 65 (37-82) 64 (32-83) 30% 27% 70% 73% 45% 49% 23% 24% 41% 38% Patients with need for immediate radiotherapy were excluded from the study but 42.3% of patients in the BSC arm required radiotherapy within the first two months on studv comoared to only 7.3% in the GEM arm. The response rate in the GEM arm’ in this randomised study is similar to that in the phase II studies being 17.4% (231132) [95% Cl = ll-24%]. An additional five patients had a >50% decrease in tumour mass but no 4 week follow-up. The mild toxicity profile of GEM was also confirmed with 92% of planned doses being given. Short lived myelosuppression was the major toxicity with grade 3 or 4 neutropenia & thrombocytopenia in 13.3% and 2.2% of pts. However only 1.4% of pts had grade 3 infection. Grade 3 or 4 toxicity >I% was seen for the following: alkaline phosphatase 1.5% grade 3. cutaneous 3.6% grade 3, nausea and vomiting 9.3% grade 3 & 0.7% grade 4, pulmonary 1.4% grade 3 8 1.4% grade 4, state of consciousness 5.0% grade 3. This randomised study confirms the previous activity and safety profile of GEM. In conclusion, surgery alone is currently considered sufficient for re- sectable NSCLC. RT, CT, surgery and combinations of these are widely used for disease that has spread to the mediastinum. CT is rarely recom- mended for metastatic disease. LT... 26 Mitomycin, ifosfamide and cisplatin (MC) in non-small cell lung cancer (NSCLC): 3. Results of a randomised trial evaluating palliation & quality of life L.J. Billingham. M.H. Cullen, J. Woods, A.D. Chetiyawardana, R.C. Joshi, J. Cook, CM. Woodroffe. University Hospital, Birmingham, UK In 1988 two randomised trials were initiated comparing chemotherapy with up to 4 courses of MIC (mitomycin 6 mg/M2. ifosfamide 3 g/M2, cisplatin 50 mg/M2 iv q21 days), plus standard treatment versus standard treatment alone in inoperable NSCLC. The MICl trial included patients with localised disease for which standard treatment was radical radiotherapy (RT), and the MIC2 trial was for more advanced cases where standard treatment was palliative care (PC-palliative RT in most cases). The principal endpoint in both trials was survival. We now report a cohort study with palliation and quality of life (QoL) as a secondary endpoint. QoL data were collected on cohorts of 68 and 121 patients from the 461 and 359 randomised cases in the MlCl & 2 trials respectively. A dedicated QoL nurse administered a questionnaire based on the EORTC QLQC30 and lung cancer module, on 4 occasions at 3-weekly intervals during treat- ment. Compliance was good with 92% of patients completing at least one questionnaire. The comparator arms were balanced for gender, age, and performance status at diagnosis. To minimize the biasing effect of attrition leading to non-random data loss, the principal treatment comparisons were based on the O-6 week change in symptoms (or C->3 wks post RT in those cases having radical RT). A descriptive analysis showed a trend for patients on the chemotherapy arms to have a superior QoL. In those with complete data for all symptoms, including side-effects, the individual scores were amalgamated to derive
Transcript of 25 Survey on the treatment of non-small cell lung cancer (NSCLC) in England and Wales
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CT group. Except for hair loss, no QOL domain differences were seen in favour of the BSC group. Median survival times were 29 weeks (CT) vs. 11 weeks (BSC). l-year survival rates were 28% (CT) vs. 8% (BSC). QOL measurements and survival curves ware similar in the randomized and non-randomized patients receiving CT.
Conclusion: Treatment with carboplatin and etoposide can improve both the quality of life and survival of patients with advanced NSCLC.
crl 23 Chemotherapy for advanced non-small lung cancer (NSCLC) is only marginally effective: Can we afford it? cl 25’ Survey on the treatment of non-small cell lung cancer
(NSCLC) in England and Wales Fergus Macbeth. Llandough Hospital, Penarth, South Glamorgan Wales, A. Crook, A. Duffy, D.J. Girling, R.L. Souhami, M.K.B. Parmar. MRCCanc. UK Trials Off, Cambridge; Middlesex Hosp., Lon., UK
Currently available cisplatin-based chemotherapy regimens are effective in prolonging survival for patients with advanced NSCLC. but the benefit is only modest in terms of survival and still uncertain in terms of quality of life. At present only a small minority of these patients in the UK receive chemotherapy.
As an adjunct to a meta-analysis comparing primary treatment + chemotherapy (CT) for NSCLC (NSCLC Collaborative Group. BMJ 1995; 311: 899-909) we conducted a survey in England and Wales to discover clinicians’ views on the role of CT in NSCLC and on what benefits from it would lead them to change their practice.
The Beatson Oncology Centre provides almost all the non-surgical oncology services to a population of 2.8 million in the West of Scotland with a budget of about f15 million. In this population there are 3,000 new cases of lung cancer, of which about 75% are NSCLC.
If 50% of these patients were now to be treated with 4 courses of cisplatin-based chemotherapy, the total cost would be about 22.6 million, a more than 15% increase in spending. These costs would probably double if taxanes were used. This amount of money is not currently available in the health-care system and would not be ‘liberated by savings in other sectors. Finally, there is no strong pressure either from the public or from the medical profession to provide this additional service.
Specialists in radiotherapy (RT), oncology, thoracic surgery, and tho- racic and palliative medicine were asked their views on the treatment of 3 case histories of 65-year-old men: case I, resected tumour involving a hilar node (T2, Nl, MO); case 2, tumour that had spread to mediastinal nodes bilaterally (T2, N3, MO): and case 3, metastatic cancer (Ml) accompanied by minor haemoptysis.
The acceptability of any medical procedure in a particular society at a particular time depends on a balance of three factors: SCIENCE (ef- fectiveness), ECONOMICS (cost and budgetary constraints), CULTURE (public and medical opinion). Chemotherapy for NSCLC is not regarded as a priority in the Scotland at present, and this view will only change when there is a significant change in any of the three factors above.
698 (85%) of the 821 clinicians responded. For case I, 74% would not recommend any adjuvant treatment, 24% would recommend RT, and <I% CT, and there was little expectation that adjuvant treatment would improve survival. For case 2,88% would recommend RT, 11% CT, and 1% surgery, 7% recommending a combination. More than 85% expected 5% or less survival beyond 5 years or median survival of 12 months or less. Adjuvant treatment, regardless of modality, was expected to improve survival. For case 3, only 11% would recommend CT, but 26% if the patient was aged 50 years or less. There was little expectation of survival beyond 1 year, or of improving it with CT. For all 3 cases, most clinicians not recommending CT would require it to achieve substantially improved survival for them to use it routinely. Radiotherapists were less likely than other clinicians to recommend CT.
El 24 Phase Ill study of gemcitabine (Gemzar@) versus best supportive care (BSC) in advanced non-small cell lung cancer (NSCLC)’
H. Anderson ‘, B. Cottiers, M. Nicolson 3, R. Milroy 4, T. Maughan 5, M. Bond 6, S. Falk’, P. Burt 8, J. Carmichael g, N. Thatcher’ on behalf of the Gemcitabine Study Group. ’ Wythenshawe Hosp., Manchester; 2 Clatterbridge Hosp. Merseyside; 3Aberdeen Royal Infirm., Aberdeen; 4Stobhi// NHS Trust, Glasgow; 5 Velindre Hosp., South Glamorgan; 6 Cookridge Hosp., Leeds; 7 United Bristol Healthcare NHS Trust, Bristol; *Christie Hosp., Manchester; gNoffingham City Hosp., Nottingham, UK
Gemcitabine (GEM) has shown a reproducible 20% response rate in NSCLC phase II trials. This UK study of GEM versus BSC enrolled 300 symptomatic pts in 26 centres between December 1994 and April 1996. One pt. withdrew consent shortly after being enrolled. GEM 1000 ms/ms was administered on days 1, 8, 15 of a 28 day schedule. This interim analysis was performed in June 1996. The two arms were well balanced with regard to stage, PS and demographics.
GEM (N = 150) WC (N = 149)
FWlales Age: median (range) KPS: 60-70
80-90 Squamous Adenocarcinoma Stage IV Disease
34% 39% 65 (37-82) 64 (32-83) 30% 27% 70% 73% 45% 49% 23% 24% 41% 38%
Patients with need for immediate radiotherapy were excluded from the study but 42.3% of patients in the BSC arm required radiotherapy within the first two months on studv comoared to only 7.3% in the GEM arm. The response rate in the GEM arm’ in this randomised study is similar to that in the phase II studies being 17.4% (231132) [95% Cl = ll-24%]. An additional five patients had a >50% decrease in tumour mass but no 4 week follow-up. The mild toxicity profile of GEM was also confirmed with 92% of
planned doses being given. Short lived myelosuppression was the major toxicity with grade 3 or 4 neutropenia & thrombocytopenia in 13.3% and 2.2% of pts. However only 1.4% of pts had grade 3 infection. Grade 3 or 4 toxicity >I% was seen for the following: alkaline phosphatase 1.5% grade 3. cutaneous 3.6% grade 3, nausea and vomiting 9.3% grade 3 & 0.7% grade 4, pulmonary 1.4% grade 3 8 1.4% grade 4, state of consciousness 5.0% grade 3. This randomised study confirms the previous activity and safety profile of GEM.
In conclusion, surgery alone is currently considered sufficient for re- sectable NSCLC. RT, CT, surgery and combinations of these are widely used for disease that has spread to the mediastinum. CT is rarely recom- mended for metastatic disease.
LT... 26 Mitomycin, ifosfamide and cisplatin (MC) in non-small cell lung cancer (NSCLC): 3. Results of a randomised trial evaluating palliation & quality of life
L.J. Billingham. M.H. Cullen, J. Woods, A.D. Chetiyawardana, R.C. Joshi, J. Cook, CM. Woodroffe. University Hospital, Birmingham, UK
In 1988 two randomised trials were initiated comparing chemotherapy with up to 4 courses of MIC (mitomycin 6 mg/M2. ifosfamide 3 g/M2, cisplatin 50 mg/M2 iv q21 days), plus standard treatment versus standard treatment alone in inoperable NSCLC. The MICl trial included patients with localised disease for which standard treatment was radical radiotherapy (RT), and the MIC2 trial was for more advanced cases where standard treatment was palliative care (PC-palliative RT in most cases). The principal endpoint in both trials was survival. We now report a cohort study with palliation and quality of life (QoL) as a secondary endpoint.
QoL data were collected on cohorts of 68 and 121 patients from the 461 and 359 randomised cases in the MlCl & 2 trials respectively. A dedicated QoL nurse administered a questionnaire based on the EORTC QLQC30 and lung cancer module, on 4 occasions at 3-weekly intervals during treat- ment. Compliance was good with 92% of patients completing at least one questionnaire. The comparator arms were balanced for gender, age, and performance status at diagnosis. To minimize the biasing effect of attrition leading to non-random data loss, the principal treatment comparisons were based on the O-6 week change in symptoms (or C->3 wks post RT in those cases having radical RT).
A descriptive analysis showed a trend for patients on the chemotherapy arms to have a superior QoL. In those with complete data for all symptoms, including side-effects, the individual scores were amalgamated to derive
