Supplementary Appendix
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1 Supplementary Appendix This appendix has been provided by the authors to give readers additional information about their work. Supplement to: Buckner JC, Shaw EG, Pugh SL, et al. Radiation plus procarbazine, CCNU, and vincristine in lowgrade glioma. N Engl J Med 2016;374: DOI: /NEJMoa
2 Supplementary Appendix Supplement to: Buckner JC, Shaw EG, Pugh SL, et al. Radiation plus procarbazine, CCNU, and vincristine in low-grade glioma Contents Figure S1. Survival Figures 2 Figure S2. Forest Plot of Hazard Ratios by Patient Subgroups 3 Table S1. Neurologic Function (NF) Status 4 Table S2. Frequency of IDH1 R132H Mutations by Histologic Type 5 Table S3. Multivariable Analyses for Progression-free Survival and Overall Survival 6 Table S4. Sensitivity Analyses to Assess Effect of Patients Lost to Follow Up on the Treatment Effect for Overall Survival 7 Table S5. Post-progression Treatment by Treatment Arm 8 Table S6. RTOG/EORTC Late Radiation Morbidity Scoring Scheme 9 1
3 2
4 3
5 Table S1. Neurologic Function (NF) Status. NF Definition 0 No neurologic symptoms; fully active at home/work without assistance. 1 Minor neurologic symptoms; fully active at home/work without assistance. Moderate neurologic symptoms; fully active at home/work but requires 2 assistance. Moderate neurologic symptoms; less than fully active at home/work and requires 3 assistance. Severe neurologic symptoms; totally inactive requiring complete assistance at 4 home or in institution-unable to work. 4
6 Table S2. Frequency of IDH1 132H Mutations by Histologic Type. Astrocytoma Mixed Oligoastrocytoma Oligdendroglioma Total IDH n % n % n % n % Negative Positive
7 Table S3. Multivariable Analyses for Progression-free Survival and Overall Survival. A) Multivariable analysis for progression-free survival Variable (Bolded value has favorable outcome) p-value Hazard Ratio (95%CI) Assigned treatment: first one year follow-up* (RT+PCV (0.33, 1.72) vs. RT alone) > 1year follow-up* (RT+PCV vs. RT < (0.12, 0.45) alone) IDH1-R132H Mutation (Absent vs. Present) (0.36, 0.93) Histology (Astrocytoma vs Oligdendroglioma) (0.26, 0.95) (Oligoastrocytoma vs Oligdendroglioma) (0.34, 0.98) *1 year was the optimal survival time which yielded the largest log partial likelihood Model derived from stepwise selection. Variable(s) not included in final model: age, gender, surgery, KPS, and contrast (dropped out during the stepwise selection process) B) Multivariable analysis for overall survival Variable (Bolded value has favorable outcome) p-value Hazard Ratio (95% CI) Assigned treatment: first one year follow-up* (RT+PCV (0.30, 4.33) vs. RT alone) > 1year follow-up* (RT+PCV vs. RT (0.19, 0.66) alone) IDH1-R132H Mutation (Absent vs. Present) (0.39, 1.12) Histology (Astrocytoma vs Oligdendroglioma) (0.18, 0.81) (Oligoastrocytoma vs Oligdendroglioma) (0.19,0.66) Age ** (<40 vs. >=40) (0.29, 0.87) *1 year was the optimal survival time which yielded the largest log partial likelihood Model derived from stepwise selection ** There is the possibility that the effect of age is confounded by resection status since patients with gross total resection must be >40 years old. Due to the limited number of patients with gross total resection in this study, further assessment is needed before conclusions can be made.. Variable(s) not included in final model: gender, surgery, KPS, and contrast (dropped out during the stepwise selection process) 6
8 Table S4. Sensitivity Analyses to Assess Effect of Patients Lost to Follow Up on the Treatment Effect for Overall Survival. 1) Keep patients lost to follow-up as censored 2) Change patients lost to follow-up on RT+PCV arm 3) Change patients lost to follow-up on RT alone arm 4) Change all patients lost to follow-up 5) Change patients lost to follow-up on RT+PCV arm (to balance number lost on each arm). Cases changed to deaths Median survival 10 year estimates Log-rank (95% CI) p-value RT alone RT+PCV RT alone RT+PCV (6.1, 9.8) (10.6, NR) 40.1% 60.1% (6.1, 9.8) (7.7, 11.66) 40.1% 49.6% (6.0, 9.0) (10.6, NR) 35.7% 60.1% < (6.0, 9.0) (7.7, 11.6) 35.7% 49.6% (6.1, 9.8) 11.6 (8.5, NR) 40.1% 56.5%
9 Table S5. Post-progression Treatment by Treatment Arm. RT Alone (n=126) RT + PCV (n=125) Cases with progression 92 (73%) 49 (39%) n n Resected Salvage chemotherapy Salvage radiotherapy/radiosurgery 33 (26%) 71 (56%) 24 (19%) 17 (14%) 29 (23%) 7 (6%) RT=radiation therapy PCV= procarbazine, CCNU, and vincristine 8
10 Table S6. RTOG/EORTC Late Radiation Morbidity Scoring Scheme. Organ Tissue 0 Grade 1 Grade 2 Grade 3 Grade 4 Grade 5 Slight atrophy; Pigmentation Patch atrophy; Moderate Marked atrophy; Gross Ulceration Skin change; Some hair loss telangiectasia; Total hair loss telangiectasia Slight induration (fibrosis) Moderate fibrosis but Severe induration and loss of Necrosis Subcutaneous and loss of subcutaneous fat asymptomatic; Slight field subcutaneous tissue; Field Tissue contracture; <10% linear contracture > 10% linear Mucous Membrane Salivary Glands Spinal Cord Brain Eye Larynx Lung Heart Esophagus Slight atrophy and dryness Slight dryness of mouth; Good response on stimulation Mild L Hermitte s syndrome Mild headache; Slight lethargy Asymptomatic cataract; Minor corneal ulceration or keratitis Hoarseness; Slight arytenoid edema Asymptomatic or mild symptoms (dry cough); Slight radiographic appearances Asymptomatic or mild symptoms; Transient T wave inversion & ST Changes; Sinus tachycardia >110 (at rest) Mild fibrosis; Slight difficulty in swallowing solids; No pain on swallowing reduction Moderate atrophy and telangiectasia; Little mucous Moderate dryness of mouth; Poor response on stimulation Severe L Hermitte s syndrome Moderate headache; Great lethargy Symptomatic cataract; Moderate corneal ulceration; Minor retinopathy or glaucoma Moderate arytenoid edema; Chondritis Moderate symptomatic fibrosis or pneumonitis severe cough); Low grade fever; Patchy radiographic appearances Moderate angina on effort; Mild pericarditis; Normal heart size; Persistent abnormal T wave and ST changes ; Low QRS Unable to take solid food normally; Swallowing semisolid food; Dilation may be indicated measurement Marked atrophy with complete dryness; Severe telangiectasia Complete dryness of mouth; No response on stimulation Objective neurological findings at or below cord level treated Severe headaches; Severe CNS dysfunction (partial loss of power or dyskinesia) Severe keratitis; Severe retinopathy or detachment Severe glaucoma Severe edema; Severe chondritis Severe symptomatic fibrosis or pneumonitis; Dense radiographic changes Severe angina; Pericardial effusion; Constrictive pericarditis; Moderate heart failure; Cardiac enlargement; EKG abnormalities Severe fibrosis; Able to swallow only liquids; May have pain on swallowing; Dilation required Ulceration Fibrosis Mono, para quadriplegia Seizures or paralysis; Coma Panopthalmitis/Blindness Necrosis Severe respiratory insufficiency/continuous O2/Assisted ventilation Tamponade/Severe heart failure/severe constrictive pericarditis Necrosis/Perforation Fistula Death directly related to radiation effects 9
11 Organ Tissue 0 Grade 1 Grade 2 Grade 3 Grade 4 Grade 5 Mild diarrhea; Mild Moderate diarrhea and colic; Obstruction or bleeding, Necrosis/Perforation Fistula cramping; Bowel movement Bowel movement >5 times requiring surgery Small/Large 5 times daily Slight rectal daily; Excessive rectal Intestine discharge or bleeding mucus or intermittent Liver Kidney Bladder Bone Joint Mild lassitude; Nausea, dyspepsia; Slightly abnormal liver function Transient albuminuria; No hypertension; Mild impairment of renal function; Urea mg%;creatinine mg%; Creatinine clearance > 75% Slight epithelial atrophy; Minor telangiectasia (microscopic hematuria) Asymptomatic; No growth retardation; Reduced bone Density Mild joint stiffness; Slight limitation of movement bleeding Moderate symptoms; Some abnormal liver; function tests; Serum albumin normal Persistent moderate albuminuria (2+); Mild hypertension; No related anemia; Moderate impairment of renal function; Urea > 36-60mg% Creatinine clearance (50-74%) Moderate frequency; Generalized telangiectasia; Intermittent macroscopic hematuria Moderate pain or tenderness; Growth retardation; Irregular bone sclerosis Moderate stiffness; Intermittent or moderate joint pain; Moderate limitation of movement Disabling hepatitic insufficiency; Liver function tests grossly abnormal; Low albumin; Edema or ascites Severe albuminuria; Severe hypertension Persistent anemia (< 10%); Severe renal failure; Urea >60 mg% Creatinine >4.0 mg% Creatinine clearance < 50% Severe frequency & dysuria Severe generalized Telangiectasia (often with petechiae); Frequent hematuria; Reduction in bladder capacity (< 150 cc) Severe pain or tenderness; Complete arrest of bone growth; Dense bone sclerosis Severe joint stiffness; Pain with severe limitation of movement Necrosis/Hepatic coma or encephalopathy Malignant hypotension; Uremic coma/urea > 100% Necrosis/Contracted bladder (capacity < 100 cc); Severe hemorrhagic cystitis Necrosis/Spontaneous fracture Necrosis/Complete fixation 10
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