Abstract

The aim was to evaluate the effects of traditional Chinese medicine (TCM) as a combination medication with adjuvant chemotherapy on postoperative early stage non-small cell lung cancer (NSCLC) patients. The 314 patients with completely resected stage IB, II or IIIA cancers were assigned into vinorelbine plus cisplatin/carboplatin (NP/NC) (control, n = 158) and NP/NC with additional TCM (intervention, n = 156) groups. The primary endpoint was QOL scores; secondary endpoints were the toxicity and safety of the regimens. The NP/NC regimen caused mild (grade 1 or 2) non-hematologic toxic effects in the patients comprising vomiting (43.6%), fatigue (36.9%), pain (23%), dry mouth (27.6%) and diarrhea (7.9%). The incidence of adverse events was significantly lower in the intervention group than in the control group (0.57% vs 4.02%, P = 0.037). Transient severe (grade 3 or 4) hematological toxic effects occurred less often (hemoglobin reduction (11.9 vs 22.5 percent) and total bilirubin increased (to 42.1 vs 46.2%) in the intervention compared to the control group during the 2nd chemotherapy cycle. When combined with adjuvant chemotherapy, TCM led to partial relief of symptoms in addition to a reduction of side-effects and adverse events caused by the NP/NC regimens.

Highlights

  • (TCM) includes mainly herbal medications and in its holistic approach TCM believes that a tumor is caused by shortness of the healthy qi, leading to organ dysfunction and the stagnation of qi and blood[5]

  • Since western medicine chemotherapy regimens have been adopted in China, TCM is mainly applied in clinical practice in combination with adjuvant chemotherapy and the formulas have been extended to cope with chemotherapy-related side effects in addition to prevention of cancer recurrence and metastasis as well as prolonging the survival time of postoperative cancer patients[7,8,9,10,11,12]

  • The primary aim of the study was to evaluate the effectiveness of TCM on QOL for postoperative NSCLC patients treated with adjuvant chemotherapy, and the secondary aim was to evaluate any beneficial effects of TCM on side effects caused by chemotherapy

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Summary

Introduction

(TCM) includes mainly herbal medications and in its holistic approach TCM believes that a tumor is caused by shortness of the healthy qi, leading to organ dysfunction and the stagnation of qi and blood[5]. Pathological products such as dirty sputum and bruises emerge and accumulate into tumor masses. A perspective randomized, double-blinded clinical trial was designed and conducted to evaluate the effects of four TCM formulations covering three different syndromes as adjunct medications, with a NP/NC regimen on clinical symptoms and QOL of postoperative NSCLC patients in comparison to a NP/NC regimen alone. The findings should help to improve adjuvant regimens for NSCLC patients after radical excision of their tumors

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