LONDON CANCER NEW DRUGS GROUP RAPID REVIEW

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1 LONDON CANCER NEW DRUGS GROUP RAPID REVIEW Adjuvant imatinib after complete resection of primary gastrointestinal stromal tumour (GIST) in patients at high risk of relapse May 2012 Summary NICE guidance issued in August 2010 did not support the use of imatinib for the adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive gastrointestinal stromal tumour (GIST), as it was not considered a cost-effective use of NHS resources. The ACOSOG Z9001 study formed the basis of the submission to NICE and showed that adjuvant imatinib administered for 12 months after surgery improved recurrence-free survival (RFS) of patients with operable GIST compared with placebo [98% imatinib group vs. 83% placebo group for the intention to treat population (hazard ratio [HR] 0.35; 95% CI, 0.22 to 0.53)], but treatment had no statistically significant impact on overall survival (OS). The Appraisal Committee considered that the data were too immature to draw conclusions about key aspects of clinical effectiveness, in particular, whether adjuvant imatinib extends overall survival, the longer-term benefits of adjuvant imatinib treatment, and the development of resistance, which could impair response to imatinib when given at a subsequent stage for metastatic GIST. In addition, the cost-effectiveness evidence was considered highly uncertain. Data from the Scandinavain Sarcoma Group (SSG) XVIII and the EORTC studies were awaited to address these uncertainties. The SSG XVIII study has recently been published, and this reported that 36 months of adjuvant imatinib treatment improved RFS (5-year RFS, 65.6% vs. 47.9%, respectively, HR. 0.46; 95% CI, ; p<0.001) and OS (5-year survival, 92.0% vs. 81.7%, HR, 0.45; ; p=0.02) of GIST patients at high risk of recurrence compared with 12 months of treatment. Twice as many patients in the 36-month treatment group (25.6% vs. 12.6%) discontinued participation in the study for reasons other than GIST recurrence: all patients experienced mild toxicities from imatinib, although more patients who were given longer therapy had high-grade adverse effects. The SMC has accepted for restricted use within NHS Scotland the use of imatinib in the adjuvant setting for patients who are at high risk of recurrence following resection, according to the Armed Forces Institute of Pathology (AFIP) risk criteria. The Committee considered that the clinical and cost-effectiveness of three years adjuvant imatinib treatment had been demonstrated. Background Imatinib is licensed for the adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive gastrointestinal stromal tumour (GIST). Patients who have a low or very low risk of recurrence should not receive adjuvant treatment. The recommended dose is 400 mg/day. The SPC states that optimal treatment duration is not yet established, but the length of treatment in the clinical trial supporting this indication was 36 months. 1 NICE guidance This was issued in August 2010 and did not support this use of imatinib as it was not considered a cost-effective use of NHS resources. 2 The randomised controlled trial, ACOSOG Z9001, was used as the clinical basis of the manufacturer s submission.* This compared 12 months of treatment with adjuvant imatinib versus placebo in patients with complete resection of primary, localised GIST. A total of 713 patients were randomised to receive either imatinib 400 mg/day (n = 359) or placebo (n = 354) within 84 days of having surgery. The primary endpoint of the study was recurrence-free survival (RFS), with overall survival (OS) included as a secondary endpoint. Patients were to be followed for a period of 5 years from the start of adjuvant treatment, or until their death. In an

2 intention-to-treat (ITT) analysis, the median length of follow-up was 19.7 months for overall survival and 14 months for recurrence-free survival. In the event of disease recurrence while on treatment, the treatment was unblinded and patients receiving imatinib 400 mg/day could have their dose escalated (to 800 mg/day), while patients receiving placebo could receive imatinib 400 mg/day. Patients whose disease progressed after completing the initial 12 months of treatment were given imatinib. The study was designed before risk stratification was introduced for GISTs, so patients could only be classified according to the size of their tumour at the point of randomisation (3 cm to below 6 cm; 6 cm to below 10 cm; and 10 cm or above). Patients were included in the study irrespective of their risk of recurrence. Of the 713 patients in the study, mitotic data were available for 556, and the manufacturer was able to retrospectively categorise these patients into subgroups according to their risk of recurrence using the Miettinen (2006) and Fletcher (2002) risk stratification tools. The four categories used were very low risk, low risk, moderate risk and high risk of recurrence. The manufacturer stated that patients at significant risk of disease recurrence (as specified in the SPC) were those in the moderate-risk and high-risk categories as defined using the Miettinen criteria. 2 The study reported the following: The rates of RFS at 1 year in the ITT population were 98% for the adjuvant imatinib group and 83% for the placebo group (hazard ratio [HR] 0.35; 95% CI, 0.22 to 0.53). In patients at significant risk of disease recurrence (relapse), the 1-year RFS were 98.3% for the imatinib group and 71.5% for the placebo group (overall HR 0.257; 95% CI, to 0.442). In patients at high risk of recurrence, the 1-year RFS rates were 98.7% for the imatinib group and 56.1% for the placebo group (overall HR 0.265; 95% CI, to 0.477). In patients at moderate risk of recurrence, the 1-year RFS rates were 97.9% for the imatinib group and 90.8% for the placebo group (overall HR 0.155; 95% CI to 0.700). No significant effect of adjuvant imatinib treatment on overall survival was indicated by the available data for the ITT population (HR 0.663; 95% CI, to 2.028) or for any of the subgroups. In the adjuvant imatinib group, slightly more patients experienced grade 3 or 4 adverse events, and there were also more instances of discontinuation of treatment and dose adjustment or interruption because of adverse events, compared with the placebo group. Severe adverse events were observed in 30.9% of patients receiving imatinib and in 18% of patients in the placebo group. The most common adverse events ( grade 3) were gastrointestinal effects and decreases in neutrophil counts, which were considered manageable with conservative treatment. Five deaths occurred in the imatinib group, none of which was caused by GIST, and 8 deaths occurred in the placebo group, five of which were caused by GIST. The numbers of serious or grade 3 4 adverse events were not reported separately for the significant-risk subgroup. Though adjuvant imatinib administered for 12 months after surgery improved RFS of patients with operable GIST compared with placebo, the data was considered by the Appraisal Committee to be too immature to draw conclusions about key aspects of clinical effectiveness, in particular whether adjuvant imatinib extends overall survival, the longer-term benefits of adjuvant imatinib treatment, and the development of resistance, which could impair response to imatinib when given at a subsequent stage for metastatic GIST. In addition, the cost-effectiveness evidence was considered highly 2

3 uncertain and the manufacturer s revised base-case ICERs were based on assumptions that were not plausible and likely to underestimate the true cost per QALY gained. The Appraisal Committee noted that greater certainty about the clinical and cost effectiveness of adjuvant imatinib would not be achievable until the following key ongoing trials have been reported: 2 Scandinavain Sarcoma Group (SSG) XVIII: a phase III, randomised, controlled collaborative study which compares 1 year versus 3 years of treatment with adjuvant imatinib in patients with a high or very high risk of disease recurrence. The primary endpoint of the study is recurrence-free survival, with overall survival included as a secondary endpoint. EORTC 62024: a phase III, randomised, placebo-controlled collaborative study which compares 24 months of treatment with adjuvant imatinib versus placebo in patients with an intermediate or high risk of disease recurrence after surgery. The primary endpoint of the study was originally overall survival, but this was changed by the trial Steering Committee in 2009 to time to failure of imatinib treatment, whether during adjuvant imatinib therapy or during subsequent treatment for recurrent disease. 2 A review of TA196 was deferred until mid 2012 in anticipation of the availability of data from both these studies. 3 Published data subsequent to NICE guidance The SSGXVIII trial was recently published. This study conducted in 24 hospitals in Finland, Germany, Norway, and Sweden randomised patients to receive imatinib, 400mg per day, for either 12 months (n= 200) or 36 months (n= 200), started within 12 weeks of surgery. The GIST was required to be histologically diagnosed, to be KIT (CD117) positive in immunostaining, and to have a high estimated risk of recurrence according to the modified National Institutes of Health (NIH) Consensus Criteria with at least 1 of the following features: (1) the longest tumour diameter > 10.0 cm (2) mitotic count > 10 mitoses per 50 high power fields of the microscope, (3) tumour diameter > 5.0 cm and mitotic count > 5, or (4) tumour rupture before surgery or at surgery. The primary end point was RFS; the secondary end points included overall survival and treatment safety. The median follow-up time after randomisation was 54 months in December Diagnosis of GIST was confirmed in 382 of 397 patients (96%) in the intention-to-treat population. KIT or PDGFRA mutation was detected in 333 of 366 tumours (91%) available for testing. Patients assigned to 36 months of imatinib had longer: RFS compared with those assigned for 12 months (hazard ratio [HR], 0.46; 95% CI, ; P<0.001; 5-year RFS, 65.6% vs 47.9%, respectively) OS (0.45; 95% CI, ; P=0.02; 5-year survival, 92.0% vs 81.7%). Imatinib was generally well tolerated, but 12.6% and 25.8% of patients assigned to the 12- and 36-month groups, respectively, discontinued imatinib for a reason other than GIST recurrence: adverse effect [27 vs. 15], patient preference [11 vs. 0], tumour histology not GIST [6 vs. 6], and other or unspecified reason [7 vs. 4]). Almost all study patients had at least 1 adverse event recorded; most events were graded mild in severity. Grade-3 or -4 adverse events occurred in 65 (32.8%) and 39 (20.1%) patients 3

4 assigned to the 36- month and 12-month groups, respectively, and adverse events leading to treatment discontinuation occurred in 27 (13.6%) and 15 (7.5%) patients, respectively. This study concluded that 36 months of adjuvant imatinib treatment improved RFS and OS of GIST patients with a high risk of GIST recurrence compared with 12 months of treatment. 4 SMC guidance The SMC in 2010 had accepted imatinib for restricted use in adult patients at high risk of recurrence following complete resection (according to the Armed Forces Institute of Pathology criteria) of Kit (CD117)-positive GISTs when used as an adjuvant treatment (a treatment to increase or aid another s effect) for 1 year only. A submission focusing on the extended use of imatinib from 1 year to 3 years, limiting use to only those patients at high risk of relapse was accepted by the SMC in March The committee noted that the clinical and cost-effectiveness of three years adjuvant imatinib treatment had been demonstrated. 5 Cost (incl VAT, MIMS May 2012) 400mg x 30 tablets = years of treatment (400mg daily) = 74,484 References 1. Novartis. GLIVEC Tablets. SPC. Date of revision ATIONS. 2. NICE. Imatinib for the adjuvant treatment of gastrointestinal stromal tumours. Technology appraisal guidance 196 (August 2010) NICE. Gastrointestinal stromal tumours - imatinib (adjuvant): review update - June Heikki Joensuu H, Eriksson M, Sundby Hall K, et al. One vs. three years of adjuvant imatinib for operable gastrointestinal stromal tumor. A Randomized Trial. JAMA. 2012;307(12): SMC. Imatinib 100mg & 400mg film-coated tablets (Glivec ). Advice March c/imatinib_glivec_2nd_resubmission * DeMatteo RP, Ballman KV, Antonescu CR et al. Adjuvant imatinib mesylate after resection of localised, primary gastrointestinal stromal tumour: a randomised, doubleblind, placebo-controlled trial. Lancet 2009; 373: Details of search strategy: NeLM NICE Cochrane Library SMC Novartis 4

5 Medline/Embase: search history: 1. EMBASE; exp IMATINIB/; results. 2. EMBASE; exp GASTROINTESTINAL STROMAL TUMOR/; 7388 results. 3. EMBASE; adjuvant.ti,ab; results. 4. EMBASE; 1 AND 2 AND 3; 339 results. 5. EMBASE; 4 [Limit to: Publication Year 2010-Current and Human and English Language]; 99 results. 6. MEDLINE; imatinib.ti,ab; 7040 results. 7. MEDLINE; exp GASTROINTESTINAL STROMAL TUMORS/; 3038 results. 8. MEDLINE; adjuvant.ti,ab; results. 9. MEDLINE; 6 AND 7 AND 8; 176 results. 10. MEDLINE; 9 [Limit to: Publication Year 2010-Current and Humans and English Language]; 51 results. 11. EMBASE,MEDLINE; Duplicate filtered: [4 [Limit to: Publication Year 2010-Current and Human and English Language]], [9 [Limit to: Publication Year 2010-Current and Humans and English Language]]; 150 results. Acknowledgements Dr Beatrice Seddon, Consultant Clinical Oncologist, The London Sarcoma Service, Department of Oncology, UCL Hospital NHS Trust Alun Pinnegar, Medical Affairs Manager, Novartis Pharmaceuticals UK Limited 5

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