Radiotherapy in palliation of thoracic tumors: a phase I–II study (SHARON project)
The main clinical goal for patients with advanced or metastatic thoracic cancer is palliation of tumor-related symptoms and improvement of quality of life. The aim of this phase I–II trial was to define the maximum tolerated dose (MTD) of a short-course of palliative radiotherapy (RT) and to evaluate its efficacy in terms of palliative response. A phase I trial was planned with escalating dose increments. Total doses ranged from 16 to 20 Gy delivered (BID) in two consecutive days. Dose limiting toxicity was defined as any acute grade ≥ 3 toxicity based on the RTOG scale. MTD was used in the phase II trial to evaluate the efficacy of this regimen using a two stage Simon’s design. Fifty-four patients were enrolled. The upper dose level of 20 Gy was defined as the MTD. In patients treated with this dose, the overall palliative response rate was 96.5% (CI 0.95: 81.3–99.9%). Complete pain relief rate was 50.0%. Median survival without symptomatic progression was 3 months. The tested short course accelerated regimen was well tolerated and effective in the palliative setting of metastatic or locally advanced chest cancer. A phase III trial is ongoing to validate this RT schedule.
Trial registration: NCT03465553.
KeywordsLung cancer Radiotherapy Palliative care Pain Quality of life Phase I–II
Clinical target volume
Dose limiting toxicity
Gross tumor volume
Maximum tolerated dose
Non-small cell lung cancer
Organs at risk
Planning target volume
Quality of life
SHort course Accelerated RadiatiON therapy
Visual Analogue self-assessment Scale
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflict of interests.
The study was approved by our institutional Ethics Committee in accordance with the Helsinki Declaration. All patients provided written informed consent before study entry.
- 1.Ferlay J, Soerjomataram I, Ervik M, Dikshit R, Eser S, Mathers C et al (2013) GLOBOCAN 2012 v1.0, Cancer incidence and mortality worldwide: IARC cancer base no. 11 [Internet]. International Agency for Research on Cancer, Lyon. http://globocan.iarc.fr. Accessed 26 July 2018
- 2.Polanski J, Jankowska-Polanska B, Rosinczuk J, Chabowski M, Szymanska-Chabowska A (2016) Quality of life of patients with lung cancer. OncoTargets Ther 9:1023–1028Google Scholar
- 4.Fairchild A, Goh P, Sinclair E, Barnes EA, Ghosh S, Danjoux C, Barbera L, Tsao M, Chow E (2008) Has the pattern of practice in the prescription of radiotherapy for the palliation of thoracic symptoms changed between 1999 and 2006 at the rapid response radiotherapy program? Int J Radiat Oncol Biol Phys 70:693–700CrossRefGoogle Scholar
- 5.Farina E, Capuccini J, Macchia G, Caravatta L, Nguyen NP, Cammelli S, Zanirato Rambaldi G, Cilla S, Wondemagegnhu T, Uddin AFMK, Sumon MA, Genovesi D, Buwenge M, Cellini F, Valentini V, Deodato F, Morganti AG (2018) Short course accelerated radiation therapy (SHARON) in palliative treatment of advanced solid cancer in older patients: a pooled analysis. J Geriatr Oncol. https://doi.org/10.1016/j.jgo.2018.01.004 CrossRefPubMedGoogle Scholar
- 6.Farina E, Capuccini J, Macchia G, Caravatta L, Nguyen NP, Cammelli S, Farioli A, Rambaldi GZ, Cilla S, Wondemagegnhu T, Uddin AFMK, Sumon MA, Genovesi D, Buwenge M, Cellini F, Valentini V, Deodato F, Morganti AG (2018) Phase I-II Study of Short-course Accelerated Radiotherapy (SHARON) for palliation in head and neck cancer. Anticancer Res 38:2409–2414PubMedGoogle Scholar
- 7.Caravatta L, Padula GDA, Macchia G, Ferrandina G, Bonomo P, Deodato F, Massaccesi M, Mignogna S, Tambaro R, Rossi M, Flocco M, Scapati A, Scambia G, Pacelli F, Valentini V, Cellini N, Morganti AG (2012) SHort course Accelerated RadiatiON therapy (SHARON) in palliative treatment of advanced pelvic malignancies: a phase I study. Int J Radiat Oncol Biol Phys 83:e627–e631CrossRefGoogle Scholar
- 8.Caravatta L, Deodato F, Ferro M, Macchia G, Massaccesi M, Cilla S, Tambaro R, Mignogna S, Padula GD, Musacchio M, Flocco M, Cantore G, Scapati A, Bogale S, Balducci M, Valentini V, Cellini N, Morganti AG (2015) Results of a phase II study of Short-course Accelerated Radiation Therapy (SHARON) for multiple brain metastases. Am J Clin Oncol 38:395–400CrossRefGoogle Scholar
- 9.Capuccini J, Macchia G, Farina E, Buwenge M, Genovesi D, Caravatta L, Nguyen NP, Cammelli S, Cilla S, Wondemagegnhu T, Uddin AFMK, Sumon MA, Cellini F, Valentini V, Deodato F, Morganti AG (2018) Short-course regimen of palliative radiotherapy in complicated bone metastases: a phase I-II study (SHARON project). Clin Exp Metastasis. https://doi.org/10.1007/s10585-018-9931-9 CrossRefPubMedGoogle Scholar
- 11.Salazar OM, Sandhu T, da Motta NW, Escutia MA, Lanzós-Gonzales E, Mouelle-Sone A, Moscol A, Zaharia M, Zaman S (2001) Fractionated half-body irradiation (HBI) for the rapid palliation of widespread, symptomatic, metastatic bone disease: a randomized Phase III trial of the International Atomic Energy Agency (IAEA). Int J Radiat Oncol Biol Phys 50:765–775CrossRefGoogle Scholar
- 15.Morgan-Fletcher SL (1999) Prescribing, recording and reporting photon beam therapy (Supplement to ICRU Report 50), ICRU Report 62. ICRU, pp ix + 52, 1999 (ICRU Bethesda, MD) $65.00 ISBN 0-91339Google Scholar
- 18.Deodato F, Cilla S, Massaccesi M, Macchia G, Ippolito E, Caravatta L, Picardi V, Romanella M, Di Falco C, Bartollino A, Valentini V, Cellini N, De Spirito M, Piermattei A, Morganti AG (2012) Daily on-line set-up correction in 3D-conformal radiotherapy: is it feasible? Tumori 98:441–444CrossRefGoogle Scholar
- 20.Rodrigues G, Videtic GM, Sur R, Bezjak A, Bradley J, Hahn CA, Langer C, Miller KL, Moeller BJ, Rosenzweig K, Movsas B (2011) Palliative thoracic radiotherapy in lung cancer: an American Society for Radiation Oncology evidence-based clinical practice guideline. Pract Radiat Oncol 1:60–71CrossRefGoogle Scholar
- 21.Senkus-Konefka E, Dziadziuszko R, Bednaruk-Młyński E, Pliszka A, Kubrak J, Lewandowska A, Małachowski K, Wierzchowski M, Matecka-Nowak M, Jassem J (2005) A prospective, randomised study to compare two palliative radiotherapy schedules for non-small-cell lung cancer (NSCLC). Br J Cancer 92:1038–1045CrossRefGoogle Scholar