Safety and efficacy of vinorelbine in combination with pertuzumab and trastuzumab for first-line treatment of patients with HER2-positive locally advanced or metastatic breast cancer: VELVET Cohort 1 final results

Perez, Edith A.; López-Vega, José Manuel; Petit, Thierry; Zamagni, Claudio; Easton, Valerie; Kamber, Julia; Restuccia, Eleonora; Andersson, Michael

doi:10.1186/s13058-016-0773-6

Table 6 Anticancer treatments received by patients after discontinuing study treatment, safety population

From: Safety and efficacy of vinorelbine in combination with pertuzumab and trastuzumab for first-line treatment of patients with HER2-positive locally advanced or metastatic breast cancer: VELVET Cohort 1 final results

INN class/preferred term^a	Cohort 1: pertuzumab, trastuzumab, and vinorelbine N = 106^b n = 90^c
HER2-targeted treatment^d,e (also counted in individual classes)
Patients who received any treatment	81 (90.0%)
Lapatinib	27 (30.0%)
Neratinib	1 (1.1%)
Pertuzumab	10 (11.1%)
Trastuzumab	57 (63.3%)
Trastuzumab emtansine	17 (18.9%)
Alkylating agents
Patients who received any treatment	6 (6.7%)
Cyclophosphamide	6 (6.7%)
Antiestrogens
Patients who received any treatment	6 (6.7%)
Fulvestrant	2 (2.2%)
Tamoxifen	4 (4.4%)
Antimetabolites
Patients who received any treatment	32 (35.6%)
Capecitabine	30 (33.3%)
Fluorouracil	1 (1.1%)
Gemcitabine	3 (3.3%)
Antineoplastic agents^f
Patients who received any treatment	19 (21.1%)
Eribulin	3 (3.3%)
Temsirolimus	1 (1.1%)
Trastuzumab emtansine	17 (18.9%)
Aromatase inhibitors
Patients who received any treatment	15 (16.7%)
Anastrozole	5 (5.6%)
Exemestane	5 (5.6%)
Letrozole	5 (5.6%)
Cytotoxic antibiotics
Patients who received any treatment	9 (10.0%)
Doxorubicin	4 (4.4%)
Epirubicin	4 (4.4%)
Mitoxantrone	1 (1.1%)
Gonadotrophin and analogs
Patients who received any treatment	2 (2.2%)
Leuprorelin	2 (2.2%)
Monoclonal antibodies
Patients who received any treatment	57 (63.3%)
Denosumab	2 (2.2%)
Pertuzumab	10 (11.1%)
Trastuzumab	57 (63.3%)
Penicillins
Patients who received any treatment	1 (1.1%)
Dicloxacillin	1 (1.1%)
Platinum compounds
Patients who received any treatment	5 (5.6%)
Carboplatin	3 (3.3%)
Cisplatin	2 (2.2%)
Surgical and medical procedures
Patients who received any treatment	22 (24.4%)
Brain tumor operation	1 (1.1%)
Breast operation	1 (1.1%)
Gamma radiation therapy to brain	1 (1.1%)
Lesion excision	1 (1.1%)
Lymphadenectomy	1 (1.1%)
Malignant tumor excision	2 (2.2%)
Mastectomy	5 (5.6%)
Radiotherapy	8 (8.9%)
Radiotherapy to brain	5 (5.6%)
Radiotherapy to lung	1 (1.1%)
Radiotherapy to lymph nodes	1 (1.1%)
Taxanes
Patients who received any treatment	24 (26.7%)
Docetaxel	10 (11.1%)
Paclitaxel	15 (16.7%)
Topoisomerase inhibitors
Patients who received any treatment	1 (1.1%)
Etoposide	1 (1.1%)
Tyrosine kinase inhibitors
Patients who received any treatment	28 (31.1%)
Lapatinib	27 (30.0%)
Neratinib	1 (1.1%)
Vinca alkaloids
Patients who received any treatment	11 (12.2%)
Vinorelbine^g	11 (12.2%)
Combinations^d (also counted in individual classes)
Patients who received any treatment	5 (5.6%)
Cisplatin/cyclophosphamide/epirubicin/etoposide/fluorouracil	1 (1.1%)
Dicloxacillin/doxorubicin	1 (1.1%)
Capecitabine/lapatinib/trastuzumab	1 (1.1%)
Carboplatin/gemcitabine	1 (1.1%)
Carboplatin/trastuzumab	1 (1.1%)

Data reported are number (%).
^aINN classes are presented alphabetically and preferred terms are sorted within INN classes alphabetically
^bNumber of patients in the safety population
^cNumber of patients who received at least one anticancer treatment after discontinuing study treatment. Percentages are based on n. Patients may have received more than one anticancer treatment after discontinuing study treatment. Some therapies began before the last study treatment was received
^dAll preferred terms within the “HER2-targeted treatment” and “Combinations” summaries are also included in their respective INN classes
^eThe “HER2-targeted treatment” summary is a reclassification of specific preferred terms, identified by the medical team
^fThe “Antineoplastic agents” summary includes any drug used to treat cancers that cannot be assigned to a more specific pharmacological class
^gEleven patients had vinorelbine (re)introduced after study treatment was discontinued: six patients who had stopped study treatment due to an adverse event/unacceptable toxicity (three of whom had not received on study vinorelbine due to AE with pertuzumab and/or trastuzumab administration and had discontinued study treatment before receiving vinorelbine as an anticancer therapy); three patients who had stopped study treatment due to administrative/other reasons; and two patients who had stopped study treatment due to disease progression

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