Nimotuzumab plus chemotherapy versus chemotherapy alone in advanced non-small-cell lung cancer: a multicenter, randomized, open-label Phase II study

Babu, K Govind; Prabhash, Kumar; Vaid, Ashok; Sirohi, Bhawna; Diwakar, Ravi B; Rao, Raghunadha; Kar, Madhuchanda; Malhotra, Hemant; Nag, Shona; Goswami, Chanchal; Raina, Vinod; Mohan, Ravi

doi:10.2147/ott.s63168

Cited by 24 publications

(17 citation statements)

References 29 publications

(46 reference statements)

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“…Other common adverse events were fatigue and gastrointestinal reaction. Nimotuzumab‐related skin draught and pruritus, which were reported previously in other studies, were not noticed in the present study . Interestingly, unlike for other EGFR inhibitors, an acne‐like rash was not observed.…”

Section: Discussionsupporting

confidence: 69%

Nimotuzumab plus paclitaxel and cisplatin as the first line treatment for advanced esophageal squamous cell cancer: A single centre prospective phase II trial

Wang

Shen

et al. 2016

Cancer Science

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Nimotuzumab (N) is a humanized anti‐epidermal growth factor receptor monoclonal antibody. This prospective, single‐armed, open label phase II study was conducted to evaluate the efficacy and safety of the combination of paclitaxel (T)/cisplatin (P) with nimotuzumab (N) as first‐line treatment in advanced esophageal squamous cell carcinoma (ESCC). Patients with pathologic confirmed unresectable locally advanced or metastatic ESCC were treated with the TPN regimen: nimotuzumab 200 mg weekly, paclitaxel 175 mg/m2 on day 1 and cisplatin 30 mg/m2 on days 1 and 2; repeat cycle every 3 weeks for six cycles. Radiotherapy was allowed to be admitted after four cycles of TPN treatment. The primary endpoint was the objective response rate (ORR). The secondary endpoint was the overall survival (OS), duration of disease control (DDC) and toxicities. From March 2011 to April 2013, a total of 59 patients were enrolled and 56 were eligible for the final analysis. Overall RR was 51.8% and disease control rate (DCR) (CR + PR + SD) was 92.9%. Local treatment (radiotherapy or surgery) followed by chemotherapy improved the duration of disease control for patients with metastatic disease and local‐regional advanced disease to 8.2 months and more than 23 months, respectively. The OS for patients with metastatic disease was 14.0 months (95% CI: 6.8–21.2 months). The most common G3/4 toxicities were neutropenia (46.4%), nausea (48.3%), alopecia (78.6%), anorexia (42.8%), vomiting (55.4%), arthralgia (62.5%) and anorexia (5%). Adding nimotuzumab to the standard TP regiment was safe, and well tolerated. The TPN regimen is an effective combination as the first‐line chemotherapy for the patients with advanced ESCC, and appears more active than current standard regimens.

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Section: Discussionsupporting

confidence: 69%

Nimotuzumab plus paclitaxel and cisplatin as the first line treatment for advanced esophageal squamous cell cancer: A single centre prospective phase II trial

Wang

Shen

et al. 2016

Cancer Science

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“…This has led to a further phase III randomized study to evaluate the efficacy of the combination of nimotuzumab with other chemotherapy drugs as a first line treatment for stage IIIB-IV NSCLC (24). A431 cells, a vulvar epidermoid carcinoma cell line with high EGFR expression demonstrated less receptor activation upon ligand binding when treated with nimotuzumab (25).…”

Section: Introductionmentioning

confidence: 99%

Antitumor activity of nimotuzumab in combination with cisplatin in lung cancer cell line A549 inï¿½vitro

Yang

Zhou

et al. 2018

Oncol Lett

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Abstract. Nimotuzumab, a humanized IgG1 monoclonal antibody against epidermal growth factor receptor (EGFR), increases radiosensitivity in lung cancer. Cisplatin is an effective antitumor agent in lung cancer. In the present study, the antitumor activity of nimotuzumab combined with cisplatin was investigated in A549 lung cancer cells. Viability, cell cycle distribution and cyclin D1 expression were assessed following treatment with nimotuzumab alone, cisplatin alone, nimotuzumab in combination with cisplatin, and nimotuzumab followed sequentially by cisplatin. The inhibitory effect on cell viability of nimotuzumab sequentially followed by cisplatin was higher compared with cisplatin alone (82.17±1.62 vs. 56.97±1.42%). Compared with treatment by cisplatin alone, cell cycle analysis by flow cytometry demonstrated that the percentage of cells in the G 0 /G 1 phase was increased when A549 cells were treated with nimotuzumab followed sequentially by cisplatin (P<0.01). However, the proportion of cells in G 0 /G 1 phase was decreased when A549 cells were treated with nimotuzumab and cisplatin simultaneously compared with cisplatin alone (P<0.05). Cyclin D1 expression was decreased in all chemotherapy treatment groups; the most significant decrease was in A549 cells treated with nimotuzumab followed sequentially by cisplatin. Nimotuzumab may enhance the antitumor activity of cisplatin on A549 cells. The cell cycle arrest at G 0 /G 1 observed may have been due to decreased cyclin D1 levels. Potential antagonism was identified when A549 cells were treated with nimotuzumab and cisplatin simultaneously, indicating that targeted therapy may be more effective when administered prior to conventional chemotherapy. IntroductionLung cancer has been the most common cancer worldwide, and the leading cause of cancer-associated mortality, since 1985 (1). The 5-year survival rate for lung carcinoma overall is poor, at 16-17% (2). Surgery is not suitable for the majority of patients with lung cancer, as diagnoses are often obtained at advanced disease stages. The standard of care for advanced non-small cell lung cancer (NSCLC) is cisplatin in combination with 1 to 3 of the following drugs: Paclitaxel, gemcitabine and docetaxel (3). The efficacy of chemotherapy is limited due to its side effects and the lack of response in certain sub-populations of patients. Research efforts have focused on identifying molecular targets and developing molecular-targeted therapies based on the understanding of the molecular abnormalities associated with lung cancer (4-6).Insight into the pathobiology of NSCLC has facilitated the development of targeted molecular therapies that target specific mutations that serve critical roles in the progression to aggressive disease. Mutations in the epidermal growth factor receptor (EGFR), KRAS and anaplastic lymphoma kinase (ALK) genes are mutually exclusive in patients with NSCLC, and targeted therapy may be affected due to the existence of one mutation in lieu of another. Therefore, the detection of these mutati...

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“…In this study, the ORR was 50% and median PFS was 6.7 months. Similarly, a previous phase II study reported an ORR of 54% in a group of NSCLC patients administered nimotuzumab plus chemotherapy …”

Section: Discussionmentioning

confidence: 62%

“…Nimotuzumab is well tolerated up to 400 mg per week . In previous clinical trials, nimotuzumab was administered in weekly doses of 200 mg or 400 mg . Considering the half life of nimotuzumab, safety, and the need for fewer infusions, nimotuzumab was administered at a dose of 400 mg on days 1 and 8 for 21 days in this study.…”

Section: Discussionmentioning

confidence: 99%

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Nimotuzumab combined with chemotherapy as first‐line treatment for advanced lung squamous cell carcinoma

Wang

et al. 2018

Thoracic Cancer

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BackgroundThis study was conducted to evaluate the efficacy and safety of nimotuzumab combined with chemotherapy as first‐line therapy in advanced lung squamous cell carcinoma (LSCC), and to explore predictive biomarkers of the efficacy of nimotuzumab.MethodsA retrospective study was conducted of patients with advanced LSCC administered nimotuzumab combined with chemotherapy as first‐line therapy from June 2012 to December 2016 at the Department of Respiratory Medicine, Peking Union Medical College Hospital. The associations between EGFR expression, EGFR gene copy numbers, and clinical efficacy were detected by immunohistochemistry and fluorescence in situ hybridization (FISH).ResultsTwenty‐six patients were enrolled, including 22 men and 4 women. The objective response rate was 50% and the disease control rate was 100%. The median progression‐free survival (PFS) and overall survival were 6.7 and 16.3 months, respectively. Patients whose samples were tested via FISH and showed positive EGFR expression had a trend of longer median PFS (10.0 months; P = 0.10). Adverse effects included 15 cases (57.7%) of bone marrow suppression, 15 (57.7%) of sensory neuropathy, 14 (53.8%) of alopecia, nine (34.6%) of nausea/vomiting and one case (3.8%) of elevated creatinine level. All adverse effects were attributed to chemotherapy.ConclusionNimotuzumab combined with chemotherapy might be a possible option as first‐line therapy in patients with advanced LSCC. EGFR gene copy number examined by FISH might be a possible predictive biomarker.

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Nimotuzumab plus chemotherapy versus chemotherapy alone in advanced non-small-cell lung cancer: a multicenter, randomized, open-label Phase II study

Cited by 24 publications

References 29 publications

Nimotuzumab plus paclitaxel and cisplatin as the first line treatment for advanced esophageal squamous cell cancer: A single centre prospective phase II trial

Nimotuzumab plus paclitaxel and cisplatin as the first line treatment for advanced esophageal squamous cell cancer: A single centre prospective phase II trial

Antitumor activity of nimotuzumab in combination with cisplatin in lung cancer cell line A549 inï¿½vitro

Nimotuzumab combined with chemotherapy as first‐line treatment for advanced lung squamous cell carcinoma

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