Standard care plan for Prophylactic Cranial Irradiation for Limited Stage (stage I-III) Small Cell Lung Cancer (25Gy in 10 fractions) References

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CHEMOTHERAPY CARE PLAN Document Title: Document Type: Subject: Approved by: Prophylactic Cranial Irradiation for Limited-stage Small Cell Lung Cancer (20Gy in 5 fractions) Clinical Guideline Standard Care Plan Currency: Review date: Author(s): Standard care plan for Prophylactic Cranial Irradiation for Limited Stage (stage I-III) Small Cell Lung Cancer (25Gy in 10 fractions) References Auperin A, Arriagada R, Pignon JP, et al. Prophylactic cranial irradiation for patients with small-cell lung cancer in complete remission. Prophylactic Cranial Irradiation Overview Collaborative Group. N Engl J Med 1999; 341:476 484. Le Pechoux C, Dunant A, Senan S, et al. Standard-dose versus higher-dose prophylactic cranial irradiation (PCI) in patients with limited-stage small-cell lung cancer in complete remission after chemotherapy and thoracic radiotherapy (PCI 99-01, EORTC 22003-08004, RTOG 0212, and IFCT 99-01): a randomised clinical trial. Lancet Oncol 2009; 10:467 474. A randomized study evaluating the optimal PCI dose in limited disease Komaki R, Meyers CA, Shin DM, et al. Evaluation of cognitive function in patients with limited small cell lung cancer prior to and shortly following prophylactic cranial irradiation. Int J Radiat Oncol Biol Phys 33 (1): 179-82, 1995 database. Patient group Limited-Stage (stage I-III) Small Cell Lung Cancer After any response to chemotherapy Filename 1.LS SCLC_PCI_Care plan Last modified 27-Mar-15 Last printed 27-Mar-15 Page 1 of 6 Agreed by (on behalf of the team) Neil Bayman

Indications Any response to chemotherapy confirmed on CT scan. No clinical/radiological evidence of brain metastases on CT or MRI Performance score (PS) of 0, 1 or 2 Contraindications No response to chemotherapy Epilepsy (suitability for PCI to be discussed on a case by case basis) Established cerebro-vascular disease (suitability for PCI to be discussed on a case by case basis) PS 3 or 4 Evidence A meta-analysis of 7 RCTs evaluating the role of PCI in patients in complete remission after chemotherapy reported improvement in brain recurrence, disease free survival and overall survival with the addition of PCI (Auperin). Prospective studies have shown that patients treated with PCI do not have significantly worse neuropsychological function than patients not treated (Auperin, Komaki). The EULINT PCI trial is a multicentre randomised controlled trial comparing high dose (36 Gy in 18 fractions) to standard dose (25 Gy in 10 fractions) radiotherapy to the whole brain. The primary end point is the reduction in the incidence of brain metastases at 2 years. The trial recruited 720 patients. Patients who received a higher PCI dose (36 Gy) had a nonsignificant decrease in brain metastases as compared with patients who received the standard dose; the brain metastases 2-year rate was 29%in the standard dose group and 23% in the high-dose group [hazard ratio 0.80, 95% confidence interval (CI) 0.57 1.11, P 0.18]. For unclear reasons, OS was worse among patients in the higher dose PCI group (hazard ratio for death 1.2, 95% CI 1.00 1.44) (Le Pechoux). Outcome Patients whose cancer can be controlled have a 60% actuarial risk of developing brain metastasis within 2 to 3 years after staring treatment. This risk can be decreased by 50% by the administration of PCI. Page 2 of 6 27/03/2015

Auperin NEJM,1999 Toxicity Lethargy, hair loss, scalp reaction, headaches, nausea 1. Initial investigations and work up prior to start of treatment 1.1. Initial diagnostic review and work up as per Limited Stage Small Cell guidelines Post chemotherapy CT scan to assess disease response. CT or MR brain if symptoms suggestive of brain metastases are present. 2. Radiotherapy Technique for PCI 2.1. Patient treatment position and set-up Simulated and treated supine with lateral parallel opposed fields. Immobilised in a thermoplastic shell Set up should be by reference to marks placed on the shell at simulation. 2.2. Patient data acquisition Page 3 of 6 27/03/2015

2.3. Target volume delineation Field definition: inferior bony landmarks of the base of the skull (Riedel s Baseline) and superior, anterior and posterior 1cm beyond the bony skull. Field projection is checked to ensure eyes/lens are spared and adjusted accordingly. 2.4. Organs at risk (delineation and dose constraints) 2.5. Dose prescription The dose will be specified at mid-plane, 25 Gy in 10 daily fractions 2.6. Verification: 2.7. Treatment Delays: 3. On treatment assessments 3.1. Clinical assessment by medical team including Graded documentation of toxicity Assessment of disease related symptoms Performance status recorded 3.2. Management of treatment related toxicity 3.2.1 Skin Reaction Topical treatment with emollient (E45 or aqueous cream) and 1% Hydrocortisone cream as required 3.2.2 Nausea and vomiting Oral anti emetics Consider oral steroids for prophylaxis/treatment of symptoms 3.2.3 Headache Simple analgesia increased as necessary Consider oral steroids for prophylaxis/treatment of symptoms Post treatment follow-up Further follow-up with referring medical oncologist. Page 4 of 6 27/03/2015

Page 5 of 6 27/03/2015

Appendices ECOG PERFORMANCE STATUS* Grade ECOG 0 Fully active, able to carry on all pre-disease performance without restriction 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2 Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours 3 Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours 4 Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair 5 Dead Page 6 of 6 27/03/2015