title: Long-term results and recurrence patterns from SCALOP: a phase II randomised trial of gemcitabine- or capecitabine-based chemoradiation for locally advanced pancreatic cancer.
abstract: BACKGROUND
  SCALOP, a randomised, phase II trial, tested the activity and safety of gemcitabine (GEM)-based and capecitabine (CAP)-based chemoradiation (CRT) for locally advanced pancreatic cancer (LAPC). Here we present the long-term outcomes.
  
  
  METHODS
  Eligibility: histologically proven LAPC ⩽7 cm. Following 12 weeks of induction GEMCAP chemotherapy (three cycles: GEM 1000 mg m-2days 1, 8, 15; CAP 830 mg m-2days 1-21 q28 days) patients with stable/responding disease, tumour ⩽6 cm, and WHO Performance Status 0-1 were randomised to receive one cycle GEMCAP followed by CAP (830 mg m-2b.d. on weekdays only) or GEM (300 mg m-2weekly) with radiation (50.4 Gy per 28 fractions).
  
  
  RESULTS
  One-hundred fourteen patients (28 UK centres) were registered between 24 December 2009 and 25 October 2011, and 74 were randomised (CAP-RT=36; GEM-RT=38). At the time of this analysis, 105 of the 114 patients had died and the surviving 9 patients had been followed up for a median of 10.9 months (IQR: 2.9-18.7). Updated median OS was 17.6 months (95% CI: 14.6-22.7) in the CAP-CRT arm and 14.6 months (95% CI: 11.1-16.0) in the GEM-CRT arm (intention-to-treat adjusted hazard ratio (HR): 0.68 (95% CI: 0.38-1.21, P=0.185)); median progression-free survival (PFS) was 12.0 months (95% CI: 10.0-15.2) in the CAP-CRT arm and 10.4 months (95% CI: 8.8-12.7) in the GEM-CRT arm (intention-to-treat adjusted HR: 0.60 (95% CI: 0.32-1.14, P=0.120)). In baseline multivariable model, age ⩾65 years, better performance status, CA19.9<613 IU l-1, and shorter tumour diameter predicted improved OS. CAP-CRT, age ⩾65 years, better performance status, CA19.9 <46 IU ml-1predicted improved OS and PFS in the pre-radiotherapy model. Nine-month PFS was highly predictive of OS.
  
  
  CONCLUSIONS
  CAP-CRT remains the superior regimen. SCALOP showed that patients with CA19.9 <46 IU ml-1after induction chemotherapy are more likely to benefit from CRT.
authors.affiliation: Centre for Trials Research, Cardiff University, 6th Floor, Neuadd Meirionnydd, Heath Park, Cardiff CF14 4YS, UK.
authors.forename: C N
authors.initials: CN
authors.lastname: Hurt
authors.affiliation: Bristol Haematology and Oncology Centre, Bristol BS2 8ED, UK.
authors.forename: S
authors.initials: S
authors.lastname: Falk
authors.affiliation: Velindre Cancer Centre, Velindre Hospital, Velindre Road, Cardiff CF14 2TL, UK.
authors.forename: T
authors.initials: T
authors.lastname: Crosby
authors.affiliation: Beatson West of Scotland Cancer Centre, 1053 Great Western Road, Glasgow G12 0YN, UK.
authors.forename: A
authors.initials: A
authors.lastname: McDonald
authors.affiliation: Centre for Trials Research, Cardiff University, 6th Floor, Neuadd Meirionnydd, Heath Park, Cardiff CF14 4YS, UK.
authors.forename: R
authors.initials: R
authors.lastname: Ray
authors.affiliation: Velindre Cancer Centre, Velindre Hospital, Velindre Road, Cardiff CF14 2TL, UK.
authors.forename: G
authors.initials: G
authors.lastname: Joseph
authors.affiliation: Velindre Cancer Centre, Velindre Hospital, Velindre Road, Cardiff CF14 2TL, UK.
authors.forename: J
authors.initials: J
authors.lastname: Staffurth
authors.affiliation: Department of Radiation Oncology, Rush University Medical Center, 500 S. Paulina, 013 Atrium Building, Chicago, IL 60612, USA.
authors.forename: R A
authors.initials: RA
authors.lastname: Abrams
authors.affiliation: Southampton Clinical Trials Unit, University of Southampton, Southampton General Hospital, Tremona Road, Southampton SO16 6YD, UK.
authors.forename: G
authors.initials: G
authors.lastname: Griffiths
authors.affiliation: CRUK MRC Oxford Institute for Radiation Oncology Gray Laboratories, Oxford University, Oxford OX3 7DQ, UK.
authors.forename: T
authors.initials: T
authors.lastname: Maughan
authors.affiliation: CRUK MRC Oxford Institute for Radiation Oncology Gray Laboratories, Oxford University, Oxford OX3 7DQ, UK.
authors.forename: S
authors.initials: S
authors.lastname: Mukherjee
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D018395:CA-19-9 Antigen / Q000097:blood*; D000069287:Capecitabine / Q000008:administration & dosage; D059248:Chemoradiotherapy; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D019583:Dose Fractionation, Radiation; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D060828:Induction Chemotherapy / Q000379:methods; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010190:Pancreatic Neoplasms / Q000097:blood / Q000473:pathology / Q000628:therapy*; D012372:ROC Curve; D012720:Severity of Illness Index; D015996:Survival Rate; D013997:Time Factors; D047368:Tumor Burden; D000093542:Gemcitabine
chemical_list: D018395:CA-19-9 Antigen; D003841:Deoxycytidine; D000069287:Capecitabine; D000093542:Gemcitabine