A phase i study of concurrent individualized, isotoxic accelerated radiotherapy and cisplatin-vinorelbine-cetuximab in patients with stage III non-small-cell lung cancer

Journal of Thoracic Oncology

Volumn 9, Issue 5, 2014, Pages 710-716

  Dingemans, Anne Marie C ^a   Bootsma, Gerben ^b   Van Baardwijk, Angela ^c   Reymen, Bart ^c   Wanders, Rinus ^c   Brans, Boudewijn ^d   Das, Marco ^a   Hochstenbag, Monique ^a   Van Belle, Arne ^a   Houben, Ruud ^c   Lambin, Philippe ^c   De Ruysscher, Dirk ^c,e  

^a MAASTRICHT UNIVERSITY   (Netherlands)

^b Sittard Geleen Heerlen   (Netherlands)

^c MAASTRO CLINIC   (Netherlands)

^d MAASTRICHT UNIVERSITY MEDICAL CENTER   (Netherlands)

^e UNIVERSITY HOSPITALS LEUVEN   (Belgium)

Author keywords

Cetuximab; Concurrent chemoradiotherapy; NSCLC; Phase I

Indexed keywords

CARBON MONOXIDE; CARBOPLATIN; CETUXIMAB; CISPLATIN; CREATININE; GEMCITABINE; HEMOGLOBIN; NAVELBINE; ANTINEOPLASTIC AGENT; DEOXYCYTIDINE; MONOCLONAL ANTIBODY; VINBLASTINE;

ADULT; AGED; AGEUSIA; ALLERGY; ALOPECIA; ANOREXIA; ARTICLE; BLOOD TOXICITY; BLURRED VISION; BURN; CANCER RADIOTHERAPY; CHEMORADIOTHERAPY; CLINICAL ARTICLE; CONSTIPATION; COUGHING; CREATININE BLOOD LEVEL; DEHYDRATION; DERMATITIS; DIARRHEA; DIZZINESS; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG SAFETY; DRY SKIN; DYSPEPSIA; DYSPHAGIA; DYSPNEA; EDEMA; ELECTROLYTE DISTURBANCE; ESOPHAGITIS; ESOPHAGUS STENOSIS; FATIGUE; FEMALE; FEVER; FORCED EXPIRATORY VOLUME; HEADACHE; HEMOGLOBIN BLOOD LEVEL; HEMOPTYSIS; HICCUP; HOARSENESS; HUMAN; HYPOCALCEMIA; HYPOKALEMIA; HYPOMAGNESEMIA; INFECTION; LEUKOPENIA; LIVER FUNCTION TEST; LOSS OF APPETITE; LUNG EMBOLISM; LUNG NON SMALL CELL CANCER; MALE; MAXIMUM TOLERATED DOSE; METABOLISM; MIDDLE AGED; MULTIPLE CYCLE TREATMENT; MUSCLE CRAMP; NAUSEA; NEPHROTOXICITY; OPEN STUDY; OTOTOXICITY; OVERALL SURVIVAL; PAIN; PARONYCHIA; PETECHIA; PHASE 1 CLINICAL TRIAL; POSITRON EMISSION TOMOGRAPHY; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PRURITUS; RADIATION DOSE; RADIATION DOSE DISTRIBUTION; RASH; REMISSION; SIDE EFFECT; STOMATITIS; THROMBOCYTE; TREATMENT OUTCOME; VOMITING; WEIGHT REDUCTION; WORLD HEALTH ORGANIZATION; ANALOGS AND DERIVATIVES; CANCER STAGING; CARCINOMA, NON-SMALL-CELL LUNG; CLINICAL TRIAL; LUNG NEOPLASMS; PATHOLOGY; PERSONALIZED MEDICINE; SCINTISCANNING;

AGED; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARBOPLATIN; CARCINOMA, NON-SMALL-CELL LUNG; CHEMORADIOTHERAPY; CISPLATIN; DEOXYCYTIDINE; FEMALE; HUMANS; INDIVIDUALIZED MEDICINE; LUNG NEOPLASMS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASM STAGING; POSITRON-EMISSION TOMOGRAPHY; RADIOTHERAPY DOSAGE; REMISSION INDUCTION; VINBLASTINE;

EID: 84899082102     PISSN: 15560864     EISSN: 15561380     Source Type: Journal    
DOI: 10.1097/JTO.0000000000000151     Document Type: Article

References (31)

1. De Ruysscher D Botterweck A Dirx M et al. Eligibility for concurrent chemotherapy and radiotherapy of locally advanced lung cancer patients: a prospective population-based study. Ann Oncol 2009;20:98-102.
2. Aupé rin A Le Pé choux C Rolland E et al. Meta-analysis of concomitant versus sequential radiochemotherapy in locally advanced non-small-cell lung cancer. J Clin Oncol 2010;28:2181-2190.
3. Goldstraw P Ball D Jett JR et al. Non-small-cell lung cancer. Lancet 2011;378:1727-1740.
4. Machtay M Paulus R Moughan J et al. Defining local-regional control and its importance in locally advanced non-small cell lung carcinoma. J Thorac Oncol 2012;7:716-722.
5. Albain KS Swann RS Rusch VW et al. Radiotherapy plus chemotherapy with or without surgical resection for stage III non-small-cell lung cancer: a phase III randomised controlled trial. Lancet 2009;374:379-386.
6. Pöttgen C Eberhardt WE Gauler T et al. Intensified high-dose chemoradiotherapy with induction chemotherapy in patients with locally advanced non-small-cell lung cancer-safety and toxicity results within a prospective trial. Int J Radiat Oncol Biol Phys 2010;76:809-815.
7. Pirker R Pereira JR von Pawel J et al. EGFR expression as a predictor of survival for first-line chemotherapy plus cetuximab in patients with advanced non-small-cell lung cancer: analysis of data from the phase 3 FLEX study. Lancet Oncol 2012;13:33-42.
8. Wang M Morsbach F Sander D et al. EGF receptor inhibition radiosensitizes NSCLC cells by inducing senescence in cells sustaining DNA double-strand breaks. Cancer Res 2011;71:6261-6269.
9. Bonner JA Harari PM Giralt J et al. Radiotherapy plus cetuximab for locoregionally advanced head and neck cancer: 5-year survival data from a phase 3 randomised trial and relation between cetuximab-induced rash and survival. Lancet Oncol 2010;11:21-28.
10. Aerts HJ Dubois L Hackeng TM et al. Development and evaluation of a cetuximab-based imaging probe to target EGFR and EGFRvIII. Radiother Oncol 2007;83:326-332.
11. Aerts HJ Dubois L Perk L et al. Disparity between in vivo EGFR expression and 89Zr-labeled cetuximab uptake assessed with PET. J Nucl Med 2009;50:123-131.
12. Mauguen A Le Pé choux C Saunders MI et al. Hyperfractionated or accelerated radiotherapy in lung cancer: an individual patient data meta-analysis. J Clin Oncol 2012;30:2788-2797.
13. van Baardwijk A Reymen B Wanders S et al. Mature results of a phase II trial on individualised accelerated radiotherapy based on normal tissue constraints in concurrent chemo-radiation for stage III non-small cell lung cancer. Eur J Cancer 2012;48:2339-2346.
14. van Baardwijk A Wanders S Boersma L et al. Mature results of an individualized radiation dose prescription study based on normal tissue constraints in stages I to III non-small-cell lung cancer. J Clin Oncol 2010;28:1380-1386.
15. Pijls-Johannesma M van Mastrigt G Hahn SM et al. A systematic methodology review of phase I radiation dose escalation trials. Radiother Oncol 2010;95:135-141.
16. Socinski MA Blackstock AW Bogart JA et al. Randomized phase II trial of induction chemotherapy followed by concurrent chemotherapy and dose-escalated thoracic conformal radiotherapy (74 Gy) in stage III non-small-cell lung cancer: CALGB 30105. J Clin Oncol 2008;26:2457-2463.
17. Young H Baum R Cremerius U et al. Measurement of clinical and subclinical tumour response using [18F]-fluorodeoxyglucose and positron emission tomography: review and 1999 EORTC recommendations. European Organization for Research and Treatment of Cancer (EORTC) PET Study Group. Eur J Cancer 1999;35:1773-1782.
18. Aerts HJ van Baardwijk AA Petit SF et al. Identification of residual metabolic-active areas within individual NSCLC tumours using a pre-radiotherapy (18)Fluorodeoxyglucose-PET-CT scan. Radiother Oncol 2009;91:386-392.
19. Govindan R Bogart J Stinchcombe T et al. Randomized phase II study of pemetrexed carboplatin and thoracic radiation with or without cetuximab in patients with locally advanced unresectable non-small-cell lung cancer: Cancer and Leukemia Group B trial 30407. J Clin Oncol 2011;29:3120-3125.
20. Blumenschein GR Jr. Paulus R Curran WJ et al. Phase II study of cetuximab in combination with chemoradiation in patients with stage IIIA/B non-small-cell lung cancer: RTOG 0324. J Clin Oncol 2011;29:2312-2318.
21. Dehing-Oberije C De Ruysscher D Petit S et al. Development external validation and clinical usefulness of a practical prediction model for radiation-induced dysphagia in lung cancer patients. Radiother Oncol 2010;97:455-461.
22. Nalbantov G Kietselaer B Vandecasteele K et al. Cardiac comorbidity is an independent risk factor for radiation-induced lung toxicity in lung cancer patients. Radiother Oncol 2013;109:100-106.
23. Petit SF van Elmpt WJ Oberije CJ et al. [18F]fluorodeoxyglucose uptake patterns in lung before radiotherapy identify areas more susceptible to radiation-induced lung toxicity in non-small-cell lung cancer patients. Int J Radiat Oncol Biol Phys 2011;81:698-705.
24. De Ruysscher D Dehing C Yu S et al. Dyspnea evolution after high-dose radiotherapy in patients with non-small cell lung cancer. Radiother Oncol 2009;91:353-359.
25. Giro C Berger B Bölke E et al. High rate of severe radiation dermatitis during radiation therapy with concurrent cetuximab in head and neck cancer: results of a survey in EORTC institutes. Radiother Oncol 2009;90:166-171.
26. Wang L Chen YZ Shi D Shi XY Zou Z Zhao JH. Incidence and risk of severe neutropenia in advanced cancer patients treated with cetuximab: a meta-analysis. Drugs R D 2011;11:317-326.
27. van den Heuvel MM Uyterlinde W Vincent AD et al. Additional weekly cetuximab to concurrent chemoradiotherapy in locally advanced non-small cell lung carcinoma: efficacy and safety outcomes of a randomized multi-center phase II study investigating. Radiother Oncol 2014;110:126-131.
28. Bradley J Masters GA Hu C et al. An intergroup randomized phase III comparison of standard-dose (60 Gy) versus high-dose (74 Gy) chemoradiotherapy (CRT) +/-cetuximab (cetux) for stage III non-small cell lung cancer (NSCLC): results on cetux from RTOG 0617. J Thorac Oncol 2013;8(suppl 2
29. Hanna N Neubauer M Yiannoutsos C et al.; Hoosier Oncology Group; US Oncology. Phase III study of cisplatin etoposide and concurrent chest radiation with or without consolidation docetaxel in patients with inoperable stage III non-small-cell lung cancer: the Hoosier Oncology Group and U.S. Oncology. J Clin Oncol 2008;26:5755-5760.
30. Vokes EE Herndon JE 2nd Kelley MJ et al.; Cancer and Leukemia Group B. Induction chemotherapy followed by chemoradiotherapy compared with chemoradiotherapy alone for regionally advanced unresectable stage III Non-small-cell lung cancer: Cancer and Leukemia Group B. J Clin Oncol 2007;25:1698-1704.
31. Roelofs E Engelsman M Rasch C et al.; ROCOCO Consortium. Results of a multicentric in silico clinical trial (ROCOCO): comparing radiotherapy with photons and protons for non-small cell lung cancer. J Thorac Oncol 2012;7:165-176.