Randomized phase II study comparing weekly docetaxel-cisplatin vs. gemcitabine-cisplatin in elderly or poor performance status patients with advanced non-small cell lung cancer

Jang, Joung Soon; Kim, Hoon Kyo; Cho, Byoung Chul; Lee, Kyung Hee; Yun, Hwan Jung; Woo, In Sook; Song, Hong Suk; Ryoo, Hun Mo; Kim, Chi Hong; Sun, Der Sheng; Shin, Jong Wook

doi:10.1007/s00280-017-3289-6

Cited by 10 publications

(11 citation statements)

References 15 publications

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“…The ORR, DCR, median PFS, and median OS of patients in the GC group were better than the DC group, but the difference was not statistically significant. These results are similar to the results of a randomized multicenter phase II study of weekly docetaxel/ cisplatin (DP, n=50 cases) and gemcitabine/cisplatin (GP, n=47 cases) as first-line treatment for elderly or advanced NSCLC patients with poor PS conducted by Jang et al (12). Gao et al (40) also reported 43 patients with advanced NSCLC who were treated with DP or GP as the first-line treatment.…”

Section: Cumulative Survivalsupporting

confidence: 82%

“…Compared with single-drug chemotherapy and optimal supportive therapy, a number of clinical studies have confirmed that platinum-based dual-drug therapy, including pemetrexed (for adenocarcinoma) (5,6), paclitaxel (albumin) (7,8), and gemcitabine (9) can prolong survival in these patients, especially those with PS 2. Some studies have also confirmed that weekly low-dose chemotherapy can result in survival benefits and less adverse effects in advanced NSCLC patients with poor PS or in the elderly (10)(11)(12)(13). However, there is no evidence for a preferred chemotherapy regimen for advanced NSCLC patients complicated with COPD and poor PS.…”

Section: Introductionmentioning

confidence: 99%

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Randomized phase III study comparing the first-line chemotherapy regimens in patients with driver mutation-negative advanced non-small cell lung cancer and poor performance status complicated with chronic obstructive pulmonary disease

Gao¹,

Zhou²,

Huang³

et al. 2021

Transl Lung Cancer Res

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Background: Patients with non-small cell lung cancer (NSCLC) complicated with chronic obstructive pulmonary disease (COPD) with poor performance status (PS) are common in clinical practice with few related studies. Present studies have found that weekly low-dose docetaxel or gemcitabine combined with platinum is suitable for elderly or poor PS patients with advanced NSCLC.Methods: Untreated advanced driver mutation-negative NSCLC patients with COPD and PS ≥2 were enrolled in this double-blind randomized trial. Both groups controlled their COPD symptoms according to the GOLD guidelines. The anti-tumor regimens included docetaxel (37.5 mg/m 2 , D1, D8)/carboplatin (AUC 5.0) (DC group) and gemcitabine (1,000 mg/m 2 , D1, D8)/carboplatin (AUC 5.0) (GC group) were used every 3 weeks with continuous chemotherapy for 4-6 cycles or until disease progression. The primary endpoints were progression-free survival (PFS), and overall survival (OS).Results: Among the 52 patients (DC, n=25; GC, n=27), the median follow-up time was 12.3 months.There was no significant difference in tumor overall response rate (ORR; DC, 20.0% vs. GC, 22.2%, P=0.845) and disease control rate (DCR; DC, 72.0% vs. GC, 74.1%, P=0.064) between the 2 groups.The median PFS (GC, 6.5 vs. DC, 5.5 months; P=0.296) and the median OS (GC, 14.9 vs. DC, 12.3 months; P=0.548) of the GC group was slightly longer than the DC group. The main adverse reactions were myelosuppression and there were few adverse reactions of grade 3-4. Compared with the anti-tumor therapy only group in previous literature, the median PFS in this study was longer (6.2 months, 95% CI: 3.533-6.733 vs. 3.5 months, 95% CI: 2.432-4.568; P=0.589). There was also no significant difference in median OS and median PFS between the 2 groups (14.0 vs. 15.0 months, P=0.718).Chemotherapy cycle (P<0.001) was an independent prognostic factor for PFS, while chemotherapy cycle (P=0.011) and PS (P=0.041) were independent prognostic factors for OS. Conclusions: Weekly low-dose docetaxel or gemcitabine combined with carboplatin chemotherapy regimens can yield survival benefits and a tolerable safety profile in patients with driver mutation-negative 2574 Gao et al. Chemotherapy regimen in NSCLC patients complicated with COPD

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Section: Cumulative Survivalsupporting

confidence: 82%

Section: Introductionmentioning

confidence: 99%

Randomized phase III study comparing the first-line chemotherapy regimens in patients with driver mutation-negative advanced non-small cell lung cancer and poor performance status complicated with chronic obstructive pulmonary disease

Gao¹,

Zhou²,

Huang³

et al. 2021

Transl Lung Cancer Res

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“…Chemotherapy has become the standard approach in the treatment of advanced NSCLC [7]. Gemcitabine/cisplatin (GP) serves as first-line doublet chemotherapy for treating advanced NSCLC, with an objective response rate of 20%, median progression-free-survival of 6.1 months, and median overall survival (OS) time of 13.1 months [8]. Unfortunately, not all the sufferers receive clinical benefits from GP chemotherapy [8].…”

Section: Introductionmentioning

confidence: 99%

“…Gemcitabine/cisplatin (GP) serves as first-line doublet chemotherapy for treating advanced NSCLC, with an objective response rate of 20%, median progression-free-survival of 6.1 months, and median overall survival (OS) time of 13.1 months [8]. Unfortunately, not all the sufferers receive clinical benefits from GP chemotherapy [8]. The majority of patients treated with GP who are GP resistance will eventually become deceased, which suggests that we need to find a suitable marker to predict GP resistance before its use.…”

Section: Introductionmentioning

confidence: 99%

Predictable Resistance and Overall Survival of Gemcitabine/Cisplatin by Platelet Activation Index in Non-Small Cell Lung Cancer

Shi

et al. 2018

Med Sci Monit

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BackgroundGemcitabine/cisplatin (GP) resistance displays a negative role in treating advanced and metastatic non-small cell lung cancer (NSCLC). Several studies found that the association existed between platelets and cancer antigen 125 (CA125) with anticancer drugs. But the exact correlation between GP resistance and platelet activation index remains poorly understood.Material/MethodsPre-chemotherapy platelet activation index and CA125 were retrospectively evaluated in 169 advanced and metastatic NSCLC patients. All variables were screened by chi-square test and then evaluated by log-rank test. Survival curves were generated by Kaplan-Meier analysis. Univariate and multivariate survival analysis were performed by using Cox proportional hazards model.ResultsThe overall rate of GP resistance for NSCLC patients was 72.19%. Mean platelet volume (MPV) and plateletcrit (PCT) are negative predictors of GP resistance adenocarcinoma [Odds ratio (OR): 5.81, 95% confidence interval (CI): 1.082–31.195, P=0.004] and squamous cell carcinoma (PCT: R: 3.517, 95% CI: 1.087–11.387, P=0.036), respectively. But both were an independent factor associated with overall survival (OS). Moreover, only CA125 was a dependent factor associated with OS for squamous cell carcinoma [OS: hazard ratio (HR): 1.741, 95% CI: 1.002–3.024, P=0.049; GP resistance: OR: 4.862, 95% CI: 1.437–16.448, P=0.011].ConclusionsPlatelet activation index will be a potential marker for predicting GP resistance. Besides, CA125 ≥16.9 could be used as a potential marker for predicting GP resistance and OS, which was more sensitive than CA125 ≥35 for squamous cell carcinoma.

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“…. 항암화학요법 중 Cisplatin과 Gemcitabine의 항암 제를 사용하는 경우 3등급 이상의 구내염 발생빈도는 47%로 [4] 구 내염으로 인한 타액 변화 및 작열감 [5,6], 연하 곤란 [7]의 구강 불편 감은 영양 섭취 저하 [8], 통증 및 전신 패혈증 [9,10]을 야기시킬 수 있다. 이는 항암제 용량 감량이나 암 치료 기간이 연장되는 결과를 초래할 수 있으므로 [11], 항암화학요법을 받는 암환자들에게 구강 안위감을 저해하는 요인을 감소시켜 줄 수 있는 간호가 치료 시작 이전에 선행되어야 한다 [12].…”

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The Effects of Oral Cryotherapy on Oral Mucositis, Reactive Oxygen Series, Inflammatory Cytokines, and Oral Comfort in Gynecologic Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Trial

Shin

Kang

2019

J Korean Acad Nurs

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The purpose of this study was to examine the effects of oral cryotherapy on oral mucositis, reactive oxygen series, inflammatory cytokines, and oral comfort in patients undergoing chemotherapy for gynecologic cancers. Methods: Participants were randomly assigned to the experimental group (n=25, receiving oral cryotherapy during chemotherapy) and the control group (n=25, receiving the usual care consisting of 0.9% normal saline gargles three times before meals). Oral mucositis was assessed using the oral assessment guide, while oral comfort was assessed using the oral perception guide. Reactive oxygen series was measured as total oxidant stress, and the level of two inflammatory markers, interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-α), were examined. The data were analyzed using t-test, chi-square test, Fisher's exact test, Mann-Whitney U-test, and repeated measures analysis of variance. Results: There was a significant difference in the oral mucositis score, reactive oxygen series score, TNF-α level, and oral comfort score between the two groups, and there were significant changes over time and in the group-by-time interactions. There was a significant difference in the IL-6 score between the two groups, but there were no significant changes over time or in the group-by-time interactions. Conclusion: The study results revealed that oral cryotherapy was more effective than the usual care regime of normal saline gargles for reducing oral mucositis, reactive oxygen series, and inflammatory cytokines and for improving oral comfort in gynecologic cancer patients undergoing chemotherapy.

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Randomized phase II study comparing weekly docetaxel-cisplatin vs. gemcitabine-cisplatin in elderly or poor performance status patients with advanced non-small cell lung cancer

Abstract: This study showed that DP is similar to GP in terms of efficacy and toxicity in treatment of elderly or poor performance patients. Both regimens showed similar grade 3/4 toxicities with different profiles.

Cited by 10 publications

References 15 publications

Randomized phase III study comparing the first-line chemotherapy regimens in patients with driver mutation-negative advanced non-small cell lung cancer and poor performance status complicated with chronic obstructive pulmonary disease

Randomized phase III study comparing the first-line chemotherapy regimens in patients with driver mutation-negative advanced non-small cell lung cancer and poor performance status complicated with chronic obstructive pulmonary disease

Predictable Resistance and Overall Survival of Gemcitabine/Cisplatin by Platelet Activation Index in Non-Small Cell Lung Cancer

The Effects of Oral Cryotherapy on Oral Mucositis, Reactive Oxygen Series, Inflammatory Cytokines, and Oral Comfort in Gynecologic Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Trial

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