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ORIGINAL ARTICLE
Year : 2017  |  Volume : 13  |  Issue : 2  |  Page : 198-203

A prospective randomized controlled study of cisplatin versus carboplatin-based regimen in advanced squamous nonsmall cell lung cancer


1 Department of Clinical Oncology, Faculty of Medicine, Ain Shams University, Cairo, Egypt
2 Department of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt

Date of Web Publication23-Jun-2017

Correspondence Address:
May Ahmed Shawki
Department of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University, Street of “African Union Organization” Beside the Ain Shams University Specialized Hospital, Abbasseya, Cairo
Egypt
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0973-1482.187287

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 > Abstract 

Background: The use of cisplatin (Cis) versus carboplatin (Carb) in the treatment of advanced nonsmall cell lung cancer (NSCLC) is controversial. The aim of the study was to compare the safety and efficacy of Cis versus Carb in squamous NSCLC.
Patients and Methods: A prospective, randomized, controlled, open-label study was conducted on advanced squamous NSCLC patients who were randomly assigned to receive Cis (40 mg/m 2 [day 1 and day 8]) or Carb (area under the curve = 5 [day 1]) combined with gemcitabine [Gem] (1000 mg/m 2 [day 1 and day 8]) of a 3-week schedule for six cycles. Study objectives were a radiological response after three cycles and six cycles, 1-year progression-free survival (PFS), 1-year overall survival (OS), and quality of life (QOL) assessment using functional assessment of cancer therapy-lung at baseline, after three cycles, and after six cycles.
Statistical Analysis: Statistical analysis was done using Statistical Package for Social Science version 15. A P < 0.05 was considered statistically significant.
Results: Seventy-one patients were enrolled (Gem/Cis group [n = 36], Gem/Carb group [n = 35]). Response rates were comparable in both arms. Nonsignificant differences were found regarding 1-year PFS (P = 0.308) and 1-year OS (P = 0.929) between the two groups. Neutropenia was significantly higher in Gem/Carb group, while vomiting and ototoxicity were significantly higher in Gem/Cis group. The effect on QOL was similar in both groups.
Conclusion: Cis and Carb have similar efficacy, tolerability, and effect on QOL and both can be used as a first-line treatment of squamous NSCLC.

Keywords: Carboplatin-cisplatin, quality of life, squamous nonsmall cell lung cancer


How to cite this article:
Saad AS, Ghali RR, Shawki MA. A prospective randomized controlled study of cisplatin versus carboplatin-based regimen in advanced squamous nonsmall cell lung cancer. J Can Res Ther 2017;13:198-203

How to cite this URL:
Saad AS, Ghali RR, Shawki MA. A prospective randomized controlled study of cisplatin versus carboplatin-based regimen in advanced squamous nonsmall cell lung cancer. J Can Res Ther [serial online] 2017 [cited 2021 Dec 4];13:198-203. Available from: https://www.cancerjournal.net/text.asp?2017/13/2/198/187287


 > Introduction Top


Lung cancer is the leading cause of cancer death all over the world. Nonsmall cell lung cancer (NSCLC) accounts for approximately 85% of all cases of lung cancer.[1] It is classified into three different subtypes: squamous cell carcinoma, large cell carcinoma, and adenocarcinoma,[2] with squamous cell carcinoma of the lung comprising approximately 30%.[3]

Platinum-based chemotherapy doublets are the backbone of treatment for NSCLC, giving a significant improvement in survival and quality of life (QOL) compared to supportive care.[4] Platinum combinations typically yield an overall response rate of 25–35%, median progression-free survival (PFS) of about 4–6 months, median overall survival (OS) of 8–10 months, and 1-year survival rate of 30–40%.[5] Cisplatin (Cis) and pemetrexed are the optimal regimens for patients with nonsquamous NSCLC, whereas platinum combined with paclitaxel, docetaxel, gemcitabine (Gem), or vinorelbine remains the standard option for patients with advanced squamous NSCLC.[6] Although Cis-based regimens have shown an advantage in prolonging survival, Cis remains a difficult drug to administer due to its toxicity (nausea and vomiting, renal dysfunction, neurotoxicity, and ototoxicity).[7],[8] Carboplatin (Carb) is frequently substituted for Cis for patients who have poor renal function or who experience toxicities from Cis.[9] Carb was the second clinically important platinum analog developed with a substantially different toxicity profile including bone marrow suppression (particularly thrombocytopenia) and a lesser incidence of gastrointestinal, renal, and neurotoxicity.[8]

There is a debate that Cis- and Carb-based chemotherapy is equally effective for advanced NSCLC.

In two different meta-analysis, Cis-based chemotherapy has shown to have a higher response rate, but the survival advantage was not significant compared to Carb-based chemotherapy.[10],[11] Another meta-analysis by Ardizzoni et al. suggested that Cis-based chemotherapy is slightly superior to Carb-based chemotherapy in terms of response rate and in prolonging survival without being associated with an increase in toxicity.[12] A retrospective study on 1014 Chinese patients has reported that NSCLC patients with Stage IIIb disease and good performance status have a better survival advantage when treated with third-generation Cis-based chemotherapy compared to Carb-based regimen, and patients with squamous histology type may have experienced greater survival benefit than those with adenocarcinoma.[13]

On the other hand, in a randomized Phase III controlled trial, it has shown that none of Cis or Carb showed a significant advantage in the treatment of advanced NSCLC.[14] In a review of ten randomized controlled trial, it has shown that there was no difference between Carb- and Cis-based chemotherapy in OS and that trials using paclitaxel or Gem plus a platin had equivalent response rates.[15] Analysis of veterans affairs central cancer registry data have shown that patients receiving Cis- and Carb-based regimens did not have significantly different survival, but Cis use was associated with an increase morbidity and healthcare use.[16] In European FRAME study, patients treated with Cis appeared to have a better survival outcome than those treated with Carb. However, when all patients in FRAME were observed, it was found that the matched subset of patients had more similar outcomes regardless of platinum treatment.[17]

Because most lung cancer is detected in later stages, when it is usually not curable, and the therapeutic options for these patients are palliative, the impact of treatment on health-related QOL should be an important consideration in treatment decisions.[18],[19]

The aim of the study was to compare treatment with Gem and Carb versus Gem and Cis alone in Egyptian patients with squamous NSCLC.


 > Patients and Methods Top


Study design and setting

A prospective, randomized, controlled, open-label study was conducted on patients with advanced squamous NSCLC. The study was carried out according to the principles set out in the Declaration of Helsinki 1964 and all subsequent revisions. Prior to participation, all the patients were educated about the study protocol and signed the written informed consent.

Patients

To be included, patients should have aged 18 years or older with histologically or cytologically confirmed Stage IV squamous NSCLC, Eastern Cooperative Oncology Group performance status of 0–2, and adequate organ function (white blood cell count ≥3000 cells/μL, with an absolute neutrophil count ≥1500 cells/μL, platelets ≥100 000/μL, and hemoglobin ≥9.5 g/dL; total bilirubin ≤1.5 × the upper limit of normal [ULN], and aspartate aminotransferase [AST] and alanine aminotransferase [ALT] concentrations ≤2.5 × ULN and serum creatinine ≤1.2 × ULN). Exclusion criteria were other primary malignancies, previous chemotherapy, clinically relevant coronary artery disease or uncontrolled congestive heart failure, severe cognitive impairment, and National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0 Grade II or worse peripheral neuropathy.

Methods

At the baseline, all the patients were subjected to physical examination, thorough history taking and assessment of baseline clinical characteristics. The patients were simply randomized to either Gem/Cis group: who received intravenous Gem 1000 mg/m 2 plus Cis 40 mg/m 2 on day 1 and day 8 of a 3-week schedule for up to six cycles or Gem/Carb group: who received intravenous Gem 1000 mg/m 2 on day 1 and day 8 plus Carb at an area under the curve of five on day 1 of a 3-week schedule for up to six cycles.

The study objectives were a radiological response after three cycles and six cycles of treatment, toxicity assessment, 1-year PFS, 1-year OS, and QOL. Radiological response was assessed with computed tomography scans after three and six cycles of treatment, using revised response evaluation criteria in solid tumors guideline (version 1.1).[20] Complete blood count, liver function tests (ALT and AST), serum creatinine, and audiometric threshold assessment were done at baseline and after each cycle. Toxicity was assessed using NCI-CTCAE version 3. PFS was defined as the time from randomization until the first radiographic documentation of objective progression, death from any cause or lost to follow-up. OS was defined as the time from treatment initiation to death from any cause or lost to follow-up.

Patients' QOL was assessed with the functional assessment of cancer therapy-lung (FACT-L)[21] at baseline and after three cycles and six cycles of treatment. The FACT-L is comprised of five subscales physical, social, family, emotional, and functional well-being; lung cancer subscale (symptoms, cognitive function, and regret of smoking). To obtain a total score of FACT-L, subscale scores were added together. Alternative scoring includes the trial outcome index (TOI), which is the sum of the physical, functional, and lung cancer subscales.

Statistical analyses

Statistical analysis was done using Statistical Package for Social Sciences, SPSS statistics for windows, version 15.0 (SPSS Inc., Chicago, III., USA). Continuous variables are expressed as a mean and standard deviation or as median (interquartile range) in cases of skewed distributions. Qualitative variables are expressed as frequencies and percentages. Student's t-test and Mann–Whitney test were used to compare a continuous variable between two study groups. Chi-square test and Fisher's exact test were used to examine the relationship between categorical variables. Correlation analysis using Spearman's method was used to assess the strength of association between two quantitative variables. Mean/median survival time was estimated and graphed using the Kaplan–Meier method. The log-rank test was used to compare time-to-event variables by levels of a factor variable. For comparisons within group regarding FACT-L/TOI scores at different points of time, paired t-test was used. A P < 0.05 was considered statistically significant.


 > Results Top


Baseline characteristics

From January 2012 to December 2015, 71 patients were enrolled in the study (36 in Gem/Cis group and 35 in Gem/Carb group). Patients' flow diagram is represented in [Figure 1]. Approximately, 55% of the patients aged <55-year-old and 77.5% of the patients were males. Forty-four patients had multiple sites. Baseline characteristics of the study groups are summarized in [Table 1].
Figure 1: Patients' flow diagram

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Table 1: Baseline characteristics of patients in the study groups

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Response evaluation

Response evaluation was available for sixty and forty patients after three cycles and six cycles, respectively. Nonresponders were patients considered to have stable disease and progressive disease, while responders were those who have a partial response. Nonsignificant differences were found regarding response rates after three cycles and six cycles between the two arms as shown in [Table 2].
Table 2: Radiological response evaluation after three cycles and six cycles of treatment

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Toxicity assessment

Most toxicities occurred in the study were low grade. Liver toxicity Grade I occurred in five patients (two in Gem/Cis group and three in Gem/Carb group), pruritus Grade I occurred in 19 patients (7 in Gem/Cis group and 12 in Gem/Carb group) and headache occurred in 24 patients (14 in Gem/Cis group and 10 in Gem/Carb group) with P= 0.647, 0.158, and 0.358, respectively. The rate of neutropenia was significantly higher in Gem/Carb group, while the rates of vomiting and ototoxicity were significantly higher in Gem/Cis group. Other toxicities were comparable between both arms as shown in [Table 3].
Table 3: Toxicity profile of gemcitabine/cisplatin versus gemcitabine carboplatin combinations

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One-year progression-free survival and 1-year overall survival evaluation

Both groups had a 1-year PFS rate of 8.3% (P = 0.308), while 1-year OS rates were 38.9% versus 40% (P = 0.929) in Gem/Cis and Gem/Carb groups, respectively. Kaplan–Meier curves for 1-year PFS and 1-year OS are represented in [Figure 2] and [Figure 3].
Figure 2: One-year progression-free survival of the study groups

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Figure 3: One-year overall survival of the study groups

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Quality of life

Both regimens have shown a significant improvement from baseline after three cycles and six cycles regarding total scores and TOI scores for both arms, and comparisons between groups regarding baseline, after three cycles and after six cycles and percent change from baseline were nonsignificant. Data are summarized in [Table 4].
Table 4: Quality of life evaluation using functional assessment of cancer therapy-lung questionnaire between the study arms

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 > Discussion Top


The current study has focused on the evaluation of different platinum-based regimens in certain histological subtype; squamous NSCLC in an advanced stage. For patients with metastatic NSCLC, the therapeutic goal is symptom and disease control, avoiding toxicity rather than cure. It is important to use a less toxic regimen, especially when there is little difference in survival. The current study has shown that Cis and Carb have comparable efficacy and toxicity and both improved patients' QOL and can be used as a first-line management of metastatic squamous NSCLC.

Although some evidence has shown that Cis is superior to Carb regarding response rates in advanced NSCLC using different regimen,[10],[11] others have shown that the response rates were similar for both of them.[7],[12],[14],[22] Using low dose Cis/Gem or Carb/Gem combinations, the current study has shown comparable response rates and this was in compliance with other results that used the same combinations.[23],[24],[25] de Castria et al. have reported in their review a higher response rate in the favor of Cis but only when it was used in high dose (80–100 mg/m 2) not the low dose (40–80 mg/m 2).[15] Using high dose Cis, Mazzanti et al. have also found comparable 1-year PFS rates for Cis/Gem and Carb/Gem combinations,[25] in compliance to the current study results.

In compliance with several studies and meta-analysis,[10],[11],[14],[15],[17],[22],[24],[25] the current study has shown that OS rates for patients treated with either Cis or Carb were almost the same. In addition, Ardizzoni et al. have reported in their meta-analysis of subgroups that survival rates of Cis and Carb were the same for squamous NSCLC despite that the OS rate for nonsquamous and squamous subtypes was in the favor of Cis.[12] It has also been reported that Cis use was associated with more hospitalization compared to Carb.[16] On the other hand, in a systematic review, a significant improvement in 1-year survival of Cis-based regimens compared to Carb-based regimens in advanced NSCLC.[7] In a retrospective study on Chinese patients with advanced squamous NSCLC, Cis has shown to be superior to Carb with respect to survival rate.[13]

The toxicity profile of Cis observed in the current study was mild, and this could be attributed to the division of Cis dose on day 1 and day 8 of the cycle. In addition, the advance in antiemetic therapy decreased the incidence of gastrointestinal side effect of Cis. The current study has shown that Cis has a significantly higher incidence of vomiting compared to Carb. However, vomiting severity was only Grade I and II. This was compliant with the results of other studies despite more severe vomiting grades have been reported with Cis use.[7],[10],[11],[12],[13],[23],[24] On the other hand, in the systemic review of de Casteria, it was reported that both Cis and Carb have comparable gastrointestinal side effects.[15] Although Carb has been reported to have higher incidence of anemia and thrombocytopenia,[7],[10],[11],[12],[13],[24] only higher incidence of neutropenia in patients treated with Carb has been reported in this study, while anemia and thrombocytopenia rate were comparable. In compliance with the results of a systematic review, renal toxicity rates were comparable in both groups.[15] On the other hand, Jiang et al. in their meta-analysis have reported higher incidence nephrotoxicity with Cis use.[11] Other toxicities were mild and comparable in both groups.

The effect of Cis and Carb on patients' QOL has not been extensively evaluated in previous studies. Overall, studies compared the effect of Cis and Carb on QOL, using different tools, have shown that they have comparable effects.[26],[27],[28] In this study, both Cis and Carb have resulted in a significant improvement of patients' QOL and their effects were comparable indicating that both treatments can be used as a first-line management of squamous NSCLC.


 > Conclusion Top


Both Cis and Carb have shown to have comparable effects on patients with squamous NSCLC regarding radiological response, PFS, OS, toxicity and QOL. Cis and Carb can be used as first line treatment in patients with squamous NSCLC.

Acknowledgment

The study protocol was revised and approved by the Research Ethics Committee of Faculty of Medicine, Ain Shams University, Cairo, Egypt.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
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    Figures

  [Figure 1], [Figure 2], [Figure 3]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4]


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