Use of [18F]-FDG PET to predict response to neoadjuvant trastuzumab and docetaxel in patients with HER2-positive breast cancer, and addition of bevacizumab to neoadjuvant trastuzumab and docetaxel in [18F]-FDG PET-predicted non-responders (AVATAXHER): An open-label, randomised phase 2 trial

The Lancet Oncology

Volumn 15, Issue 13, 2014, Pages 1493-1502

  Coudert, Bruno ^a   Pierga, Jean Yves ^b   Mouret Reynier, Marie Ange ^c   Kerrou, Kaldoun ^d   Ferrero, Jean Marc ^e   Petit, Thierry ^f   Kerbrat, Pierre ^g   Dupré, Pierre François ^h   Bachelot, Thomas ⁱ   Gabelle, Philippe ^j   Giard, Sylvia ^k   Coeffic, David ^l   Bougnoux, Philippe ^m   Prevost, Jean Briac ⁿ   Paintaud, Gilles ^o   Thibault, Gilles ^m   Hernandez, Juana ^p   Coudert, Mathieu ^q   Arnould, Laurent ^a   Berriolo Riedinger, Alina ^a  

^a CENTRE GEORGES FRANÇOIS LECLERC   (France)

^b INSTITUT CURIE   (France)

^c CENTRE JEAN PERRIN   (France)

^d HÔPITAL TENON   (France)

^e CENTRE ANTOINE LACASSAGNE   (France)

^f CENTRE PAUL STRAUSS   (France)

^g CENTRE EUGÈNE MARQUIS   (France)

^h BREST UNIVERSITY HOSPITAL   (France)

ⁱ CENTRE LÉON BÉRARD   (France)

^j Institut Daniel Hollard   (France)

^k CENTRE OSCAR LAMBRET   (France)

^l Clinique Hartmann   (France)

^m CHU BRETONNEAU   (France)

ⁿ Department of Medical Oncology   (France)

^o UNIVERSITÉ DE TOURS   (France)

^p Laboratoire Roche Pharma   (France)

^q EXPERIS IT   (France)

more..

Author keywords

[No Author keywords available]

Indexed keywords

BEVACIZUMAB; DOCETAXEL; EPIDERMAL GROWTH FACTOR RECEPTOR 2; FLUORODEOXYGLUCOSE F 18; TRASTUZUMAB; ANTINEOPLASTIC AGENT; ERBB2 PROTEIN, HUMAN; MONOCLONAL ANTIBODY; RADIOPHARMACEUTICAL AGENT; TAXOID;

ABDOMINAL PAIN; ADJUVANT THERAPY; ADULT; ALOPECIA; AMENORRHEA; ANEMIA; ARTHRALGIA; ARTICLE; ASTHENIA; BACKACHE; BRAIN DISEASE; BREAST CANCER; BREAST SURGERY; CANCER ADJUVANT THERAPY; CANCER COMBINATION CHEMOTHERAPY; CANCER PROGNOSIS; CANCER RADIOTHERAPY; CANCER SURGERY; CANCER SURVIVAL; CHOLESTASIS; CLOSTRIDIUM DIFFICILE INFECTION; COGNITIVE DEFECT; CONSTIPATION; CONTROLLED STUDY; COUGHING; CYTOLYTIC HEPATITIS; DECREASED APPETITE; DEPRESSION; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; DRY SKIN; DYSGEUSIA; DYSPNEA; EPIDERMAL GROWTH FACTOR RECEPTOR 2 POSITIVE BREAST CANCER; EPISTAXIS; FEBRILE BONE MARROW APLASIA; FEBRILE NEUTROPENIA; FEMALE; FEVER; FRANCE; HAND FOOT SYNDROME; HEADACHE; HEALING IMPAIRMENT; HEART EJECTION FRACTION; HOT FLUSH; HUMAN; HUMAN TISSUE; HYPERTENSION; HYPOGLYCEMIA; INTENTION TO TREAT ANALYSIS; LACRIMATION; LUNG DISEASE; LUNG EMBOLISM; LYMPH NODE; MAJOR CLINICAL STUDY; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MYALGIA; NAIL DISEASE; NAIL INFECTION; NAUSEA; NEUROLOGIC DISEASE; NEUROTOXICITY; NEUTROPENIA; NOSE NECROSIS; ONYCHOLYSIS; OPEN STUDY; PARESTHESIA; PELVIS ABSCESS; PERIANAL ABSCESS; PERIPHERAL EDEMA; PERIPHERAL NEUROPATHY; PHARYNGITIS; PHASE 2 CLINICAL TRIAL; PHLEBITIS; POSITRON EMISSION TOMOGRAPHY; PREDICTION; PREDICTIVE VALUE; PRIORITY JOURNAL; RADIOLOGICAL PARAMETERS; RANDOMIZED CONTROLLED TRIAL; RASH; RHINOPHARYNGITIS; SENSORY NEUROPATHY; SEPSIS; SOMNOLENCE; STANDARDIZED UPTAKE VALUE; SURGICAL INFECTION; TREATMENT OUTCOME; UNCONSCIOUSNESS; UNSPECIFIED SIDE EFFECT; VOMITING; WEIGHT GAIN; ADJUVANT CHEMOTHERAPY; BREAST NEOPLASMS; CANCER GRADING; CANCER STAGING; CARCINOMA, DUCTAL, BREAST; CLINICAL TRIAL; DIAGNOSTIC USE; FOLLOW UP; LYMPH NODE METASTASIS; METABOLISM; MIDDLE AGED; MORTALITY; MULTIMODALITY CANCER THERAPY; PATHOLOGY; PROGNOSIS; SCINTISCANNING; SECONDARY; SURVIVAL RATE;

ADULT; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; CARCINOMA, DUCTAL, BREAST; CHEMOTHERAPY, ADJUVANT; COMBINED MODALITY THERAPY; FEMALE; FLUORODEOXYGLUCOSE F18; FOLLOW-UP STUDIES; HUMANS; LYMPHATIC METASTASIS; MIDDLE AGED; NEOADJUVANT THERAPY; NEOPLASM GRADING; NEOPLASM STAGING; POSITRON-EMISSION TOMOGRAPHY; PROGNOSIS; RADIOPHARMACEUTICALS; RECEPTOR, ERBB-2; SURVIVAL RATE; TAXOIDS;

EID: 84920478749     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(14)70475-9     Document Type: Article

References (32)

1. Buzdar AU, Ibrahim NK, Francis D, et al. Significantly higher pathologic complete remission rate after neoadjuvant therapy with trastuzumab, paclitaxel, and epirubicin chemotherapy: results of a randomized trial in human epidermal growth factor receptor 2-positive operable breast cancer. J Clin Oncol 2005, 23:3676-3685.
2. Gianni L, Eiermann W, Semiglazov V, et al. Neoadjuvant chemotherapy with trastuzumab followed by adjuvant trastuzumab versus neoadjuvant chemotherapy alone, in patients with HER2-positive locally advanced breast cancer (the NOAH trial): a randomised controlled superiority trial with a parallel HER2-negative cohort. Lancet 2010, 375:377-384.
3. Amat S, Bougnoux P, Penault-Llorca F, et al. Neoadjuvant docetaxel for operable breast cancer induces a high pathological response and breast-conservation rate. Br J Cancer 2003, 88:1339-1345.
4. Coudert BP, Arnould L, Moreau L, et al. Pre-operative systemic (neo-adjuvant) therapy with trastuzumab and docetaxel for HER2-overexpressing stage II or III breast cancer: results of a multicenter phase II trial. Ann Oncol 2006, 17:409-414.
5. Guiu S, Liegard M, Favier L, et al. Long-term follow-up of HER2-overexpressing stage II or III breast cancer treated by anthracycline-free neoadjuvant chemotherapy. Ann Oncol 2011, 22:321-328.
6. Ferrara N, Davis-Smyth T The biology of vascular endothelial growth factor. Endocr Rev 1997, 18:4-25.
7. Presta LG, Chen H, O'Connor SJ, et al. Humanization of an anti-vascular endothelial growth factor monoclonal antibody for the therapy of solid tumors and other disorders. Cancer Res 1997, 57:4593-4599.
8. Miller KD, Chap LI, Holmes FA, et al. Randomized phase III trial of capecitabine compared with bevacizumab plus capecitabine in patients with previously treated metastatic breast cancer. J Clin Oncol 2005, 23:792-799.
9. Miles DW, Chan A, Dirix LY, et al. Phase III study of bevacizumab plus docetaxel compared with placebo plus docetaxel for the first-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol 2010, 28:3239-3247.
10. Miles DW, Dieras V, Cortes J, Duenne AA, Yi J, O'Shaughnessy J First-line bevacizumab in combination with chemotherapy for HER2-negative metastatic breast cancer: pooled and subgroup Analyses of data from 2447 patients. Ann Oncol 2013, 24:2773-2780.
11. Pierga JY, Petit T, Delozier T, et al. Neoadjuvant bevacizumab, trastuzumab, and chemotherapy for primary inflammatory HER2-positive breast cancer (BEVERLY-2): an open-label, single-arm phase 2 study. Lancet Oncol 2012, 13:375-384.
12. + breast cancer. Clin Breast Cancer 2011, 11:297-305.
13. Pegram M, Chan D, Dichmann R, Anderson D Phase II combined biological therapy targeting the HER2 proto-oncogene and the vascular endothelial growth factor using trastuzumab (T) and bevacizumab (B) as first line treatment of HER2-amplified breast cancer. Breast Cancer Res Treat 2006, 100(suppl 1). abstr 301.
14. Untch M, Fasching PA, Konecny GE, et al. Pathologic complete response after neoadjuvant chemotherapy plus trastuzumab predicts favorable survival in human epidermal growth factor receptor 2-overexpressing breast cancer: results from the TECHNO trial of the AGO and GBG study groups. J Clin Oncol 2011, 29:3351-3357.
15. Cortazar P, Zhang L, Untch M, et al. Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis. Lancet 2014, 384:164-172.
16. 18F]-FDG PET early identification of non responding HER2 positive breast cancer patients treated with trastuzumab. Médecine Nucléaire Imagerie Fonctionnelle et Métabolique 2008, 32:206-207. (in French).
17. 18F-FDG tumor metabolism after a first course of neoadjuvant chemotherapy in breast cancer: influence of tumor subtypes. Ann Oncol 2012, 23:2572-2577.
18. Groheux D, Giacchetti S, Hatt M, et al. HER2-overexpressing breast cancer: FDG uptake after two cycles of chemotherapy predicts the outcome of neoadjuvant treatment. Br J Cancer 2013, 109:1157-1164.
19. Wolff AC, Hammond EH, Schwartz JN, et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. J Clin Oncol 2007, 25:118-145.
20. 18F]FDG-PET predicts complete pathological response of breast cancer to neoadjuvant chemotherapy. Eur J Nucl Med Mol Imaging 2007, 34:1915-1924.
21. Chevallier B, Roche H, Olivier JP, Chollet P, Hurteloup P Inflammatory breast cancer: pilot study of intensive induction chemotherapy (FEC-HD) results in a high histologic response rate. Am J Clin Oncol 1993, 16:223-228.
22. Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 2009, 45:228-247.
23. Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Last update National Cancer Institute, (accessed March 25, 2014). http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm.
24. von Minckwitz G, Eidtmann H, Rezai M, et al. Neoadjuvant chemotherapy and bevacizumab for HER2-negative breast cancer. N Engl J Med 2012, 366:299-309.
25. Bear HD, Tang G, Rastogi P, et al. Bevacizumab added to neoadjuvant chemotherapy for breast cancer. N Engl J Med 2012, 366:310-320.
26. Gianni L, Pienkowski T, Im YH, et al. Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial. Lancet Oncol 2012, 13:25-32.
27. Koolen BB, Pengel KE, Wesseling J, et al. FDG PET/CT during neoadjuvant chemotherapy may predict response in ER-positive/HER2-negative and triple negative, but not in HER2-positive breast cancer. Breast 2013, 22:691-697.
28. 18F-FDG PET/CT for early prediction of response to neoadjuvant lapatinib, trastuzumab, and their combination in HER2-positive breast cancer: results from Neo-ALTTO. J Nucl Med 2013, 54:1862-1868.
29. Chen XL, Lei YH, Liu CF, et al. Angiogenesis inhibitor bevacizumab increases the risk of ischemic heart disease associated with chemotherapy: a meta-analysis. PLoS One 2013, 8:e66721.
30. Choueiri TK, Mayer EL, Je Y, et al. Congestive heart failure risk in patients with breast cancer treated with bevacizumab. J Clin Oncol 2011, 29:632-638.
31. Gianni L, Romieu GH, Lichinitser M, et al. AVEREL: a randomized phase III trial evaluating bevacizumab in combination with docetaxel and trastuzumab as first-line therapy for HER2-positive locally recurrent/metastatic breast cancer. J Clin Oncol 2013, 31:1719-1725.
32. Telli ML Insight or confusion: survival after response-guided neoadjuvant chemotherapy in breast cancer. J Clin Oncol 2013, 31:3613-3615.