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24 Outcomes with erlotinib (Tarceva®) in a Yorkshire cancer centre
Posters, 5th Annual BTOG Meeting, 2007 endpoint is response rate (radiological and pathological). Secondary endpoints are safety and tolerability of the combination, resection rate following therapy, overall survival and relapse free survival. In addition, molecular prognostic and predictive biomarkers of response are being assessed. Sequential samples of tissue, plasma, serum and white blood cells are being collected before, during and after therapy from all patients. Results: 24 patients have been recruited to date (14 men, 10 women) Median age 66 (range 29 77), 19 patients stage I, 2 patients stage II, 3 patients stage III. 18 have completed treatment. Response (RECIST guidelines); CR 1 patient, PR 15 patients, SD 6 patients, PD 1 patient. The most common toxicity was skin rash (100%). Grade 3/4 toxicities were neutropenia (73%) and thrombocytopenia (45%). There were 2 grade 3 and 3 grade 4 cardiovascular toxicities in patients with significant co-morbid cardiovascular toxicities. Conclusions: The response rate is consistent with that established for neoadjuvant chemotherapy. Ongoing biomarker studies may identify those patients most likely to benefit from induction treatment. 23 The financial onus of Erlotinib: Is it really more expensive? A.R. Abdul Razak, L. Li, S. Gill, J. Gardiner, A. Hughes. Department of Medical Oncology, Northern Centre for Cancer Treatment (NCCT), Newcastle Upon Tyne, UK Introduction: Erlotinib has been proven to be an effective treatment for incurable non-small cell lung cancer in a second/third line setting. However, the use of this drug has been perceived to be associated with higher costs. We have constructed a financial model in order to estimate the cost per patient treated with erlotinib, compared to docetaxel, the current National Institute of Clinical Excellence (NICE) approved agent used in this setting. Methods: We have built a financial model which consists of patients treated with erlotinib and docetaxel respectively. From existing published and presented data, together with local audit figures, the costs of utilising each agent were calculated. In addition, consumption of personnel time, chemotherapy day unit chair utilisation as well as costs of major treatment related complications were considered. All parameters were then averaged per patient. Results: The cost of drug acquisition as well as treating major complications arising from treatment for erlotinib and docetaxel, per patient was £6622 and £4822 respectively. However, there was a net decrease, per patient, of personnel time (2.4 hours) and chemotherapy day unit chair time (4.1 hours) utilisation in favour of Erlotinib. Conclusion: Considering the indirect savings from personnel time and chemotherapy day unit chair time utilisation, the use of erlotinib should be considered as a cost effective alternative treatment in this setting. 24 Outcomes with erlotinib (Tarceva®) in a Yorkshire cancer centre L. O’Toole, M. Bond, M. Snee. Cookridge Hospital, Leeds, LS16 6QB, UK Introduction: Erlotinib inhibits the tyrosine kinase activity of epidermal growth factor receptor (EGFR). EGFR is central to many cellular processes and is often found in non small cell lung cancer (NSCLC) cells. Erlotinib is used in our cancer centre as a second line agent for patients with NSCLC. Patients have at least one of four factors predicting a favourable response; adenocarcinoma or bronchio-alveolar histologies, are non-smokers or of Asian ethnicity. Methods: The outcomes for patients treated with erlotinib from May 2005 to July 2006 were of interest. An audit was performed with particular attention to indication, outcomes and toxicity.
S7 Results: To July 2006, 35 patients had received erlotinib through Cookridge Hospital. The objective x-ray response rate was 29.4%. Progression free survival was months (95% confidence interval (C.I.) 1.47 4.67 months). Overall survival was 6.4 months (95% C.I. 5.6 7.2 months). Dose was reduced in 4 patients due to rash and because of increased liver function tests in a further 2. Treatment was interrupted in one patient because of rash and in one because of hemiparesis. One patient discontinued treatment after 3 days due to nausea. Conclusions: Erlotinib is a safe and effective agent in the second line management of selected patients with NSCLC. 25 FRAGMATIC. A randomised phase III clinical trial investigating the effect of FRAGMin® added to standard therapy in patients with lung cancer F. Macbeth, S. Noble, S.J. Linnane. Velindre Hospital, Cardiff, UK Aim: To assess the effect of adding 24 weeks of daily dalteparin (Fragmin®) to standard treatment for patients with lung cancer. Outcome measures: The primary outcome measure is overall survival and the secondary outcome measures include; venous thrombotic event free survival, metastasis-free survival, quality of life, cost effectiveness and cost utility. Sample size: To detect an advantage of 5% in overall survival at 1 year (to 30%) a total of 2200 patients are required (1100 in each arm). Main inclusion criteria: Histopathological or cytological diagnosis of primary bronchial carcinoma within the last 6 weeks, Performance status 0, 1, 2 or 3, willing and able to receive daily subcutaneous injection. Main exclusion criteria: Other intrathoracic tumours, brain metastases, known bleeding disorder, platelet count <100·109 /L, creatinine >150 mmol/L, haemoptysis of > CTC Grade 2. Study duration: 1 December 2006 1 December 2009
Radiotherapy 26 X-ray volumetric imaging (XVI) to quantitate the dosimetric impact of the uncertainties during radical radiotherapy (RT) of non small cell lung cancers P. Jain, T. Marchant, M. Duffy, P.A. Burt, C. Faivre-Finn, M. Harris, R. Stout, C. Moore, P. Price. Christie Hospital, Manchester, UK Introduction: X-ray volumetric imaging (XVI) is a way of acquiring 3-D reconstructed CT scans, of a patient in treatment position during RT. RT planning incorporates data on tumour position, respiration and patient position; which can all vary during RT and introduce uncertainty. These are presently accounted by using large margins when planning RT. The study aim was to look at the dosimetric impact of these uncertainties, identified using XVI scans, on the planned dose. Method: 12 patients with mobile lung tumours, undergoing radical radiotherapy, were recruited into the study. Patients were setup, planned and treated according to standard protocols. 55 Gy were delivered in 20 fractions. XVIs were acquired daily for d1 5, d16 20 and weekly for the intervening weeks. These were coregistered with the planning CT scan to obtain bony setup errors. The gross lung tumour volume (GTV) and normal organs were contoured and delivered dose calculated on the XVIs. Results: Nine patients were suitable for analysis. The systematic set up errors in the lateral, vertical and longitudinal axes were 3.4, 3.3 and 6 mm respectively with random errors between 1.5 3.4 mm in the three axes. GTV reduction seen during treatment was 15.2%. Reduction in the isocentre, mean GTV
S7 Results: To July 2006, 35 patients had received erlotinib through Cookridge Hospital. The objective x-ray response rate was 29.4%. Progression free survival was months (95% confidence interval (C.I.) 1.47 4.67 months). Overall survival was 6.4 months (95% C.I. 5.6 7.2 months). Dose was reduced in 4 patients due to rash and because of increased liver function tests in a further 2. Treatment was interrupted in one patient because of rash and in one because of hemiparesis. One patient discontinued treatment after 3 days due to nausea. Conclusions: Erlotinib is a safe and effective agent in the second line management of selected patients with NSCLC. 25 FRAGMATIC. A randomised phase III clinical trial investigating the effect of FRAGMin® added to standard therapy in patients with lung cancer F. Macbeth, S. Noble, S.J. Linnane. Velindre Hospital, Cardiff, UK Aim: To assess the effect of adding 24 weeks of daily dalteparin (Fragmin®) to standard treatment for patients with lung cancer. Outcome measures: The primary outcome measure is overall survival and the secondary outcome measures include; venous thrombotic event free survival, metastasis-free survival, quality of life, cost effectiveness and cost utility. Sample size: To detect an advantage of 5% in overall survival at 1 year (to 30%) a total of 2200 patients are required (1100 in each arm). Main inclusion criteria: Histopathological or cytological diagnosis of primary bronchial carcinoma within the last 6 weeks, Performance status 0, 1, 2 or 3, willing and able to receive daily subcutaneous injection. Main exclusion criteria: Other intrathoracic tumours, brain metastases, known bleeding disorder, platelet count <100·109 /L, creatinine >150 mmol/L, haemoptysis of > CTC Grade 2. Study duration: 1 December 2006 1 December 2009
Radiotherapy 26 X-ray volumetric imaging (XVI) to quantitate the dosimetric impact of the uncertainties during radical radiotherapy (RT) of non small cell lung cancers P. Jain, T. Marchant, M. Duffy, P.A. Burt, C. Faivre-Finn, M. Harris, R. Stout, C. Moore, P. Price. Christie Hospital, Manchester, UK Introduction: X-ray volumetric imaging (XVI) is a way of acquiring 3-D reconstructed CT scans, of a patient in treatment position during RT. RT planning incorporates data on tumour position, respiration and patient position; which can all vary during RT and introduce uncertainty. These are presently accounted by using large margins when planning RT. The study aim was to look at the dosimetric impact of these uncertainties, identified using XVI scans, on the planned dose. Method: 12 patients with mobile lung tumours, undergoing radical radiotherapy, were recruited into the study. Patients were setup, planned and treated according to standard protocols. 55 Gy were delivered in 20 fractions. XVIs were acquired daily for d1 5, d16 20 and weekly for the intervening weeks. These were coregistered with the planning CT scan to obtain bony setup errors. The gross lung tumour volume (GTV) and normal organs were contoured and delivered dose calculated on the XVIs. Results: Nine patients were suitable for analysis. The systematic set up errors in the lateral, vertical and longitudinal axes were 3.4, 3.3 and 6 mm respectively with random errors between 1.5 3.4 mm in the three axes. GTV reduction seen during treatment was 15.2%. Reduction in the isocentre, mean GTV