Med Oncol (2011) 28:1418–1424
DOI 10.1007/s12032-010-9575-3
ORIGINAL PAPER
Comparison of cisplatin- and carboplatin-based third-generation
chemotherapy in 1,014 Chinese patients with advanced
non-small-cell lung cancer
Jie Luo • Shiang J. Leaw • Ying Xu •
Di Zheng
Received: 9 March 2010 / Accepted: 17 May 2010 / Published online: 27 July 2010
Ó Springer Science+Business Media, LLC 2010
Abstract The outcome of patients with stage IIIB/IV non-
small-cell lung cancer treated with platinum-based che-
motherapy as first-line therapy was investigated to deter-
mine if cisplatin- or carboplatin-based combination therapy
have similar efficacy by comparing the overall survival and
safety profile for each combination regimen. A total of
1,014 patients, treated for stage IIIB and IV NSCLC
between January 2002 and December 2008, with initial
ECOG performance status of 0 and 1, adequate hemato-
logic, hepatic, and renal function, who received at least two
cycles of third-generation platinum-based chemotherapy,
survived greater than 90 days, and experienced death were
included for survival and safety analysis. Of them, 788
patients received cisplatin-based chemotherapy and 226
carboplatin-based. Cisplatin-based regimen yield signifi-
cant better overall survival with a median survival time of
324 days compared to that of the carboplatin-based regimen
of 286 days, attributable to the survival benefit of patients
with stage III B (379 days vs. 283 days, Log-rank P =
0.003), or with histology of squamous (308 days vs.
262 days, Log-rank P = 0.01). Patients of the carboplatin-
based arm were more likely to experience thrombocytope-
nia (OR = 0.560, 95% CI = 0.332–0.944, P = 0.028),
while cisplatin-based chemotherapy was associated with
more nausea and vomiting (OR = 3.720, 95% CI = 1.971–
7.021, P \ 0.0001). Non-small-cell lung cancer patients
J. Luo
Y. Xu
D. Zheng (&)
Department of Medical Oncology, Shanghai Pulmonary
Hospital, Tongji University School of Medicine,
507 Zhengmin Road, 200433 Shanghai, China
e-mail: zhengdiok@hotmail.com
S. J. Leaw
Department of Medical Oncology, Fudan University Shanghai
Cancer Center, 270 Dongan Road, 200032 Shanghai, China
123
with stage IIIB disease and good performance status have a
better survival advantage when treated with third-genera-
tion cisplatin-based chemotherapy compared to carbo-
platin-based regimen, and patients with squamous histology
type may have experienced greater survival benefit than
those with adenocarcinoma.
Keywords Advanced non-small-cell lung cancer

Chemotherapy
Cisplatin
Carboplatin
Overall survival
Introduction
Lung cancer, the most common cancer since 1985 [1],
remains the leading cause of death from cancer worldwide,
with a 5-year survival rate of only 15%, despite great
improvement in early detection and treatment as the
majority of patients present with advanced disease at
diagnosis [2]. Non-small-cell lung cancer (NSCLC)
accounts for approximately 85% of all cases of lung can-
cer. The incidence of lung cancer, 62.1 per 100,000 pro-
jected in 2005 [3], has been on the rise and became the
leading cause of cancer in China, among which estimated
127,000 deaths were attributable to smoking [4].
With increasing understanding of the mechanisms of
cancer pathogenesis at the molecular level and more tar-
geted therapeutic agents on the horizon, the treatment of
locally advanced and metastatic NSCLC has progressed to
the new era of molecular-based individualized therapy.
For example, gefitinib may be recommended for patients
with known epidermal growth factor receptor (EGFR)
mutation as first-line therapy. Still, platinum-based two-
drug combination of chemotherapy remains the recom-
mended standard of care as first-line therapy for NSCLC
patients with ECOG PS of 0–1 [5].
Med Oncol (2011) 28:1418–1424 1419

Cisplatin, used since early 1970s against various Received chemotherapy for all settings between 2002-2008
n=5983
cancers, has been the backbone of combination chemo-
therapy in NSCLC, but substantial toxicities that include
Death Events occurred on or before Aug 31 of 2009
severe renal, neurologic, and emetogenic effects are often n=3378

reported. Carboplatin, an analog of cisplatin, introduced

since 1981 to help circumvent some of the toxicities of Received chemotherapy only for NSCLC stage IIIB/IV disease
n=2032
cisplatin, has replaced cisplatin in various chemotherapy
regimens for the treatment of ovarian carcinoma, but there Received platinum-based third generation chemotherapy regimen as first-line therapy
n=1593
is evidence for the inferiority of carboplatin compared with
cisplatin in the treatment of germ cell and head-and-neck
Documented survival time ≥ 90 days and PS 0-1
tumors [6]. However, whether carboplatin-based regimen is n=1014
as effective as cisplatin-based regimen for the treatment of
advanced and metastatic NSCLC is still a debatable issue Fig. 1 Flow of patient selection from the Lung Cancer Patient
as results were inconsistent even after many randomized, Registry for chemotherapy
controlled trials were performed [7–18]. Cisplatin is gen-
erally preferred in Europe [19], while carboplatin is more
likely to be used in the United States [20]. In the most based on the initial diagnosis of advanced NSCLC, where
recent individual patient data–based meta-analysis, where standard first-line chemotherapy using third-generation
data of 2,968 patients from nine prospective, randomized chemotherapeutic agents was provided. Examination of
trials were examined to compare cisplatin- with carbo- 5,983 patient records between January 2002 and December
platin-based combination chemotherapy as the first-line 2008 revealed 1,014 eligible patients, who fit the inclusion
treatment for advanced and metastatic NSCLC [21]. criteria for the analysis. Details are presented in Fig. 1.
Ardizzoni et al found that cisplatin-based chemotherapy is
slightly superior to carboplatin-based chemotherapy in
Inclusion criteria
terms of response rate (30 vs. 24%, respectively; OR =
1.37; 95% CI = 1.16 to 1.61; P \ 0.001), and subgroup
All patients had pathological and radiological confirmation
analysis revealed that carboplatin treatment was associated
of newly diagnosed stage IIIB or IV NSCLC between 18
with a statistically significant increase in mortality among
and 80 years of age who received at least two cycles of
patients treated with third-generation platinum-based reg-
third-generation platinum-based therapy chemotherapy.
imens and those with non-squamous tumors (HR = 1.11;
In order to avoid selection bias due to physicians’ prefer-
95% CI = 1.01 to 1.21 and HR = 1.12; 95% CI = 1.01 to
ence, of which carboplatin-based regimens are more likely
1.23, respectively).
to be used in patients with poor PS and inadequate renal
In order to determine whether carboplatin has similar
function, only patients with initial ECOG PS score B 1,
efficacy with cisplatin in this setting in China, we inves-
adequate hematologic parameters, normal hepatic and renal
tigated the outcome of patients with stage IIIB and IV
function presented on the first admission, a documented
NSCLC treated with third-generation platinum-based che-
survival time greater than 90 days and who experienced
motherapy regimens as first-line treatment in our depart-
death on follow-up were included. Patients were excluded
ment from January 2002 to December 2008 by comparing
if they received both cisplatin- and carboplatin-based reg-
the overall survival (OS) and safety profile for each com-
imen for first-line treatment and if inpatient documentation
bination regimen.
is incomplete. Radiotherapy was acceptable for cases with
oncology emergencies if indicated and in which the irra-
diated area did not include the target lesions. Patients with
Materials and methods
symptomatic brain metastases on admission were excluded.
This retrospective analysis was conducted using data from
the Lung Cancer Patients Registry for chemotherapy in the Data collection
Department of Medical Oncology at Shanghai Pulmonary
Hospital, a well-established comprehensive hospital for All patient records between January 2002 and December
pulmonary disease with an annual rate of 2,000 newly 2008 were reviewed to identify those meeting the inclusion
diagnosed lung cancer cases. All cases had been treated as criteria. Baseline demographics including age, gender, per-
inpatient and regularly follow up for responses and survival formance status, disease status, and histology were obtained
after completion of chemotherapy, whether as adjuvant, for each patient, as well as the date of original diagnosis with
first-line or second-line settings. Patients were selected NSCLC. A complete history of the first-line treatment each

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1420 Med Oncol (2011) 28:1418–1424

patient had received for NSCLC was recorded, including the Table 1 Patient characteristics
start and stop dates of chemotherapy, drugs received, reason DDP arm CBP arm P value
for discontinuation, best response, adverse events experi- (n = 788) (n = 226)
enced during treatment, and date of death, and where
Age
applicable, reason for death was obtained. Objective tumor
responses were recorded using WHO criteria. Toxicity was B70 643(81.6%) 180(79.6%) 0.508
recorded according to the National Cancer Institute’s [70 145(18.4%) 46(20.4%)
Common Terminology Criteria for Adverse Events (NCI- Sex
CTC) versions 2.0. All survival data were obtained through Male 561(71.2%) 159(70.4%) 0.806
admission documents or phone calls to the family members Female 227(28.8%) 67(29.6%)
of the subjects. Stage
IIIB 248(31.5%) 82(36.3%) 0.174
IV 540(68.5%) 144(63.7)
Statistical analysis
Pathology
Adenocarcinoma 482(61.2%) 141(62.4%) 0.664
Survival time was defined as the time elapsed from the
Squamous 214(27.2%) 65(28.8%)
initiation of chemotherapy to death. No data were censored
Undefined NSCLC 33(4.1%) 8(3.5%)
because all death events had occurred. OS was analyzed
Mixed adenocarcinoma/ 59(7.5%) 12(5.3%)
using the Kaplan–Meier method. The log-rank test was squamous
used for comparison of OS curve. Multivariate analyses Chemotherapy agents
were performed using Cox regression models. Expected
Vinorelbine 356(45.2%) 92(40.7%) 0.271
prognostic factors including age (\70 years vs. C70),
Gemcitabine 212(26.9%) 59(26.1%)
gender (male vs. female), clinical stage (IIIB vs. IV), and
Docetaxel 128(16.2%) 38(16.8%)
histology (adenocarcinoma vs. non-adenocarcinoma) were
Paclitaxel 92(11.7%) 37(16.4%)
used for multivariate analyses. For categorical variables,
initial statistical comparisons were performed with Pearson
chi-squared test. All reported two-sided values of less than
0.05 were considered statistically significant. All the Survival
analyses were performed by the SPSS v 13.0 for Windows.
OS for patients of the DDP arm was significantly greater than
the OS of the patients of the CBP arm (MST 324 vs.
Results 286 days, Log-rank P = 0.013; HR = 0.813, 95% CI =
0.700–0.943, P = 0.006). Figure 2 shows the Kaplan–Meier
Patient characteristics curve for OS. Survival rate at 1 year was 42.8% for the DDP
arm and 32.7% for the CBP arm, with significant difference
Among the 1,014 patients included for analysis, 788 received observed at P = 0.007 (OR 1.535, 95% CI, 1.124–2.096).
cisplatin-based (DDP arm) chemotherapy, while 226 Details were presented in Table 2.
received carboplatin-based (CBP arm) regimen. The Subgroup analysis based on disease status and histology
majority of patients was younger than 70 years and most type demonstrated that cisplatin-based regimen was associ-
presented with stage IV disease for both arms. Treatment ated with greater survival gain among patients with stage
regimens included either cisplatin or carboplatin combined IIIB disease compared to stage IV disease (stage IIIB: 379 vs.
with one of the following chemotherapeutic agents: vino- 283 days, respectively, Log-rank P = 0.003; HR = 0.659,
relbine, gemcitabine, docetaxel, and paclitaxel, which were 95% CI = 0.511–0.850, P = 0.001; stage IV: 301 vs.
administered via a 21-day cycle with the following dose and 286 days, respectively, Log-rank P = 0.316; HR = 0.894,
schedule: cisplatin 75 mg/m2 on day 1, carboplatin AUC 5 95% CI = 0.743–1.075, P = 0.233). Patients with squa-
on day 1, vinorelbine 25 mg/m2 on day 1 and 8, gemcitabine mous histology were associated with significantly more
1,000 mg/m2 on day 1 and 8, docetaxel 75 mg/m2 on day 1, survival gain than adenocarcinoma histology (squamous:
and paclitaxel 135 mg/m2 on day 1. The most commonly 308 vs. 262 days, respectively, Log-rank P = 0.01; HR =
used third-generation chemotherapy agents in the combina- 0.763, 95% CI = 0.570–0.932, P = 0.043; adenocarci-
tion regimens were vinorelbine and gemcitabine. There were noma: 349 vs. 293 days, respectively, Log-rank = 0.110;
no significant differences noted between the characteristics HR = 0.842, 95% CI = 0.697–1.017, P = 0.074). Survival
presented at baseline for both arms. Patients’ characteristics curves for the subgroup analysis were displayed on Figs. 3,
were presented in Table 1. 4, 5, and 6.

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Med Oncol (2011) 28:1418–1424 1421

Fig. 2 The comparison of overall survival between CBP and DDP

Fig. 4 Subgroup analysis: the comparison of overall survival of
arm
patients with stage IV disease

Table 2 Comparison of efficacy between DDP and CBP Arm

Efficacy DDP CBP Odds 95% CI P
arm (%) arm (%) ratio value

1-year 42.8(337/788) 32.7(74/226) 1.535 1.124–2.096 0.007

survival
rate
Response 32(252/788) 25.7(58/226) 1.362 0.975–1.902 0.069
rate

Fig. 5 Subgroup analysis: the comparison of overall survival of

patients with squamous histology

histology type (HR = 0.806, 95% CI = 0.702–0.927, P =

0.002) were independent prognostic factors for better progno-
sis, while age maybe not related with the prognosis. Details
were presented in Table 3.

Fig. 3 Subgroup analysis: the comparison of overall survival of
patients with stage IIIB disease
On multivariate analysis, stage IIIB (HR = 0.854, 95%
CI = 0.746–0.979, P = 0.023), female gender (HR = 1.286,
95% CI = 1.112–1.489, P = 0.001), adenocarcinoma
Toxicity
Comparison of the frequencies of NCI-CTC grade 3/4
hematologic and non-hematologic adverse events were
presented in Table 4. Patients of the CBP arm were more
likely to experience thrombocytopenia compared to those
of DDP arm (OR = 0.560, 95% CI = 0.332–0.944,

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to our hospital for third-generation platinum-based che-

motherapy from 2002 to 2008. In order to minimize the
influence of uncontrolled bias, a specific group of patients
were selected through highly restricted inclusion criteria so
that the heterogeneity of subjects would be diminished.
Overall survival time was chosen to be the primary end
point rather than progression-free survival time, to prevent
the potential bias related to determination of cancer pro-
gression based on investigators’ interpretation of radio-
graphic images in an open-label trial [22], especially when
blinded independent central review (BICR) was absent in
this retrospective study. Only patients with death event
were included so that the influence of censored survival
data could be avoided. The multivariate analysis performed
supported our initial assumption that the distribution of this
population would be similar to other well-established series
with stage IIIB, female gender, and adenocarcinoma his-
Fig. 6 Subgroup analysis: the comparison of overall survival of
patients with adenocarcinoma histology tology type as the independent prognostic factor for better
survival. Carboplatin at a dose of AUC 5 in combination
with other chemotherapeutic agents has been the standard
Table 3 Prognostic factors for advanced NSCLC treated with plati- of care in our institution based on previous experience and
num-based regimens
similar studies that had documented the feasibility and
Parameter Hazard ratios 95% CI P value tolerability of these combination regimens, which has also
Staging (IIIB vs. IV) 0.854 0.746–0.979 0.023
been observed in a later study [15, 23–25] The carboplatin
Sex (male vs. female) 1.286 1.112–1.489 0.001
dose used in the studies included in Ardizzoni’s meta-
Pathology (ad vs. non-ad) 0.806 0.702–0.927 0.002
analysis was AUC 5 and 6 for two and four trials,
respectively. Presently, there is no existing data that con-
Age (B70 vs. [70) 0.957 0.814–1.126 0.598
cluded that a dose–response effect is associated with plat-
inum agents within the range of doses of AUC 5 and 6, also
P = 0.028), whereas the frequencies of leucopenia and noted by Ardizzoni [21].
anemia were comparable in both groups. Cisplatin-based Our analysis demonstrated superiority for cisplatin-
chemotherapy was associated with more nausea and vomit- based third-generation chemotherapy for stage IIIB/IV
ing than carboplatin-based chemotherapy (OR = 3.720, NSCLC with greater gain in MST, which is consistent with
95% CI = 1.971–7.021, P \ 0.0001), while there is no the subset analysis of Ardizzoni’s. Our results were very
significant difference in the incidence of nephrotoxicity and similar to the findings of Rosell [13], one of the studies
hepatotoxicity between the two groups. included in the analysis, where cisplatin-based combination
regimen yield longer median OS (9.7 vs. 8.2 months,
HR = 1.22, 95% CI = 1.03–1.43, P = 0.019). However,
Discussion our reported survival advantage of cisplatin-based regimen
associated with stage IIIB or squamous histology type, and
This is a retrospective study of NSCLC patients with newly observed trend in the adenocarcinoma type even though
diagnosed Stage IIIB or IV disease admitted consecutively insignificant, is different from the meta-analysis [21].

Table 4 Comparison grade 3/4 adverse events between DDP and CBP arm
Grade 3/4 adverse events DDP arm % CBP arm % Odds ratio 95% CI P value

Anemia 12.9(102/788) 11(25/226) 1.195 0.751–1.903 0.451

Leucopenia 26(205/788) 19.9(45/226) 1.414 0.984–2.034 0.061
Thrombocytopenia 6(47/788) 10.2(23/226) 0.560 0.332–0.944 0.028
Nephrotoxicity 1.9(15/788) 1.3(3/226) 1.442 0.414–5.027 0.563
Nausea & vomiting 16(126/788) 4.8(11/226) 3.720 1.971–7.021 \0.0001
Hepatotoxicity 3(24/788) 2.7(6/226) 1.152 0.465–2.853 0.760

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Med Oncol (2011) 28:1418–1424
A thorough examination of the Ardizzoni et al.’s meta-
analysis [21] revealed large number of patients with squamous
tumors who received older-generation chemotherapy were
included. First- and second-generation platinum-based che-
motherapy was used in the Klastersky’s [10] series, while the
Jelic’s [11] series was flawed by imbalance of PS, a well-
established prognostic factor in NSCLC, favoring the carbo-
platin arm, with a ratio of 59/52 and 70/35 for patients with PS
0–1 and PS [ 1, for cisplatin group and carboplatin group,
respectively [7]. And both series included the majority of the
squamous histology type, 50% for the prior and 100% for the
latter, respectively. This is in contrast to the other seven trials
included where between 20–30% were of squamous histology
and all patients received third-generation platinum-based
chemotherapy. This could result in no survival benefit seen
among patients with squamous tumors. Compared to Ar-
dizzoni et al.’s [21] meta-analysis, a smaller sample size may
explain for the insignificant difference noted in OS for patients
with adenocarcinoma histology in our series.
The well-established conclusion on the equivalence of
carboplatin- and cisplatin-based combination regimen in
terms of OS in the ECOG 1594 [14] is controversial
because the overwhelming population of stage IV popula-
tion (86–89%) would override the advantage of survival
resulting from stage IIIB patients treated with cisplatin- vs.
carboplatin-based therapy. Our series reported cisplatin-
based regimen was associated with significant survival gain
among patients with stage IIIB disease compared to stage
IV disease, which is in parallel to other trials where at least
30% of patients enrolled were stage IIIB [10–13, 15–18].
The different toxicity profile of cisplatin and carboplatin
had also been confirmed, which is consistent with the lit-
erature. More grade 3 and 4 nausea/vomiting occurred in
the DDP arm, while more grade 3 and 4 thrombocytopenia
were reported in the CBD arm.
In conclusion, NSCLC patients with less advanced dis-
eases (stage IIIB vs. IV) and good PS (0–1 vs. 2 more) could
have a better survival advantage when third-generation
cisplatin-based combination therapy is used compared to
carboplatin-based regimen, and patients with squamous
histology type may have experienced greater survival ben-
efit than those with adenocarcinoma. Randomized, pro-
spective trials comparing cisplatin vs. carboplatin against
specific NSCLC subgroups may be needed, especially for
patients with squamous histology as they are most often
excluded from clinical trials studying targeted therapy.
Acknowledgments We would like to thank Caifen Wu, RN, for her
enormous effort in follow-up with all the patients listed in the reg-
istry. This work was supported by Shanghai Municipal Natural Sci-
ence Foundation 10ZR1424900.
Conflict of interest statement All authors have no conflicts of
interest.
1423
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