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A. Garcia



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    O14 - Radiotherapy - Toxicity and Clinical Trials (ID 105)

    • Event: WCLC 2013
    • Type: Oral Abstract Session
    • Track: Radiation Oncology + Radiotherapy
    • Presentations: 1
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      O14.07 - IDEAL CRT: Isotoxic Dose Escalation and Acceleration in Lung Cancer ChemoRadiotherapy - a phase I/II trial of concurrent chemoradiation with dose-escalated radiotherapy in patients with stage II or stage III Non-Small Cell Lung Cancer. (ID 1368)

      11:35 - 11:45  |  Author(s): A. Garcia

      • Abstract
      • Presentation
      • Slides

      Background
      The IDEAL-CRT trial uses an individual patient approach to radiotherapy (RT) dose escalation, escalating the dose within a fixed overall treatment time, 6 weeks, by increasing dose per fraction. Isotoxic RT is based on the calculated risk of RT-pneumonitis (RTPN), RT dose being escalated so that all patients are exposed to the same RTPN risk. We investigated the feasibility and safety of individualised, isotoxic dose escalation for once daily RT delivered in 30 once-daily fractions with concurrent chemotherapy.

      Methods
      Eligibility; NSCLC stage II/III, PS 0/1, FEV~1~ (≥40% predicted or ≥1L), DCLO (≥40% predicted). A radiobiological model was used to individualize RT dose-prescription – selecting a dose which, in 30# once daily for 6 weeks, is associated with a 10% risk of grade 3+ RTPN, but limiting prescribed doses to between 63Gy - 73Gy (2Gy dose equivalent α:β=10, 63.5Gy-86Gy). Dose constraints were fixed for spinal cord, heart, brachial plexus. In Arm 1, initially the maximum dose to 1cc oesophageal did not exceed 63Gy. Arm 2 comprised patients in whom oesophageal dose rather than lung dose limited the prescription dose: the oesophageal dose was raised from 65Gy to 68Gy, 71Gy and 73Gy in consecutive cohorts, the prescribed dose lying between 63Gy and 73Gy and being the highest consistent with the oesophageal limit. Dose escalation was determined using a 6+6 design. Dose limiting toxicity (DLT) was defined as Grade 3+ oesophagitis. MTD was determined if grade 3+ oesophagitis >42% (>5/12). Two cycles of Cisplatin-Vinorelbine chemotherapy given concurrently during RT. All contouring and dosimetry on planning CT scans was centrally reviewed. IMRT was introduced in November 2012. Primary endpoints: oesophagitis and RTPN. Serial pulmonary function tests and ECGs performed. Efficacy endpoints: overall survival (OS), progression free survival (PFS), and tumour response.

      Results
      Between October 2010 and February 2013, 84 patients recruited (9 UK centres), 49 patients Arm 1, 35 patients Arm 2 (13 at 65Gy, 12 at 68Gy, 10 at 71Gy; none at 73Gy as the 73Gy upper prescription dose limit was only rarely associated with an oesophageal dose higher than 71Gy). Median follow up was 11 months (range 2,24); median age 66 years (range 43-84); 74% male; 39%/60% WHO 0/1; 30% adenocarcinoma, 54% squamous. Mean GTV 121cc (range 14-602cc). Mean prescribed dose for patients completing RT (n=80) 67.6Gy (range 63-73Gy) in Arm 1 and 70.1 Gy (63-73) in Arm 2. Mean 1cc-oesophageal-dose in Arm 1 55.5Gy (range 14.2-68.0Gy). In Arm 1 grade 3+ oesophagitis was 6% (3/49). In Arm 2, Grade 3+ oesophagitis was 17% (2/12) at 68Gy; no Grade 3+ oesophagitis in 65Gy (0/12) and 71Gy (0/10) cohorts. Grade 3+ RTPN 2% (1/49) in Arm 1 and 6% (2/35) in Arm 2. 1 year OS and PFS rates were 92% and 74% respectively.

      Conclusion
      Isotoxic RT dose escalation was safe and feasible. The MTD for oesophagus was not reached. Acceleration of the IDEAL-CRT schedule to five weeks is under investigation in a second study, currently recruiting.

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    P3.08 - Poster Session 3 - Radiotherapy (ID 199)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Radiation Oncology + Radiotherapy
    • Presentations: 1
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      P3.08-022 - Survival analysis of Hypo-fractionated Radical Radiotherapy for the treatment of Non-Small-Cell Lung Cancer using 55Gy in 20 fractions: The North Wales Cancer Centre Experience (ID 2651)

      09:30 - 09:30  |  Author(s): A. Garcia

      • Abstract

      Background
      Hypo fractionated radical radiotherapy using 55 Gy in 20 fractions is one of the most commonly used radical radiotherapy regimens in the UK. The shorter overall treatment time has the radio-biological advantage of minimal re-population. Despite its popularity in UK, there is paucity of supporting data in the reported literature. We present the mature outcome data of this regimen based on the single centre experience in North Wales Cancer Centre,UK.

      Methods
      A retrospective case note analyses of Non-Small-Cell Lung Cancer patients who underwent radical radiotherapy using 55Gy in 20 fraction (fraction size that 2.75 Gy/fraction), between 2001 and 2011, was carried out. We included the patients who had the total dose reduced to 52.5 Gy in 20 fractions to allow for normal tissue constraints. Patients receiving concurrent chemoradiation and adjuvant radiotherapy after surgical resection were excluded. The records were updated using the national registry of death in Wales. Univariate analyses of the effects of different subgroups on overall survival were performed.

      Results

      Table 1. Stage and Histological distribution
      No of patients
      stage IA 27
      IB 35
      IIA 8
      IIB 30
      IIIA 52
      IIIB 66
      IV 1
      Unknown 3
      Histology NOS 37
      Non-Squamous 44
      Squamous 95
      Unknown 46
      Total 222 patients (128 males, 94 females) underwent radical radiotherapy between 2001 and 2011. Median follow up period was 267 weeks (range 74-637). Mean age at diagnosis was 68 yr (41-91). The stage and histological distribution is shown in table 1. Of the stage III patients 81 had induction chemotherapy before the radiotherapy. The median survival of the whole group was 124 weeks (95% CI 105-141) and the survival by histology and stages is shown in table 2. The good 2 yr but poor 5 yr OS of the Stage I patients may reflect their poorer general health at presentation that rendered them medically inoperable. Table 2. Overall survival by Stage and Histological Subgroups
      Median OS in Weeks (95% C.I.) 2 yr OS 5 yr OS
      stage stage 1 135 (116-210) 68% 28% p= 0.47
      stage 2 135 (80-264) 58% 42%
      stage 3 105 (85-141) 50% 27%
      Histology NOS 73 (60-102) 30% 10% p= 0.0004
      Non-Squamous 131 (114-216) 67% 25%
      Squamous 130 (97-162) 57% 35%
      Unknown 191 (131-325) 67% 38%

      Conclusion
      Radical Radiotherapy using 55 Gy in 20 fractions is a highly effective form of treatment for early and locally advanced stages of Non-Small-Cell Lung Cancer with results comparable to isofractionated radiotherapy published in the literature.