What was the Effect of Taxol in Non-Metastatic Non-Small Cell Lung Cancer Patients in Mansoura University Hospital?
Manal Mostafa Saleh Elghareeb, Hend M Hamdey Rashed Elkalla*, Mohamed Saad Elashry and Ahmed Elshahat
Clinical Oncology and Nuclear Medicine Department, Mansoura University Hospital, Egypt
Submission: August 04, 2017; Published: August 10, 2017
*Corresponding author: Hend M Hamdey Rashed Elkalla, Lecturer at Faculty of Medicine, Mansoura University Hospital, Clinical Oncology and Nuclear Medicine department, Egypt, Tel: 00201210200602; Email: firstname.lastname@example.org
How to cite this article: Manal M S E, Hend M H R E, Mohamed S E, Ahmed E. What was the Effect of Taxol in Non-Metastatic Non-Small Cell Lung
Cancer Patients in Mansoura University Hospital?. Canc Therapy & Oncol Int J. 2017; 6(4): 555691. DOI: 10.19080/CTOIJ.2017.06.555691
Introduction: Lung cancer has been turned from a rare disease to a worldwide problem. Non-small cell lung cancer (NSCLC) is the most commonly diagnosed type of lung cancer forming about 85% of all cases. Measures for treatment in NSCLC include: surgical resection, radiotherapy, chemotherapy and targeted therapy. They can be used as solo modality or in combination. Taxanes as paclitaxel and docetaxel are important classes of chemotherapeutic agents.
Aim of the work: The aim of our retrospective study is to evaluate the role of taxol based chemotherapy in treatment of non-metastatic NSCLC.
Patient & methods: Between January 2008 and December 2013, thirty five patients with newly diagnosed, non- metastatic NSCLC were included for this analysis. Between January 2008 and December 2013, thirty five patients with newly diagnosed, non- metastatic NSCLC were included for this analysis. The patients received paclitaxel containing regimens. All were combined either with carboplatin (33 patients) or with cisplatin (2 patients).
Results: As regard response rate only one patient achieved complete response, partial response was detected in 18 patients, stationary disease was demonstrated in 12 patients and 4 patients had progressive disease. The most common toxicity was the hematological toxicity. The median PFS was 8 months (95% Confidence Interval, 6.774 -9.226 months). The median OS was 13 months (95% Confidence Interval, 10.533 –15.467 months).
Conclusion: Taxol is active class of chemotherapeutic agents in NSCLC and well tolerated.
Lung cancer has been turned from a rare disease to a worldwide problem. The deaths in USA were 160,340 in 2012 due to lung cancer. In USA, it was responsible for 28% of all cancer mortality. Changing the location does not affect markedly the global lung cancer mortality, with 43% of deaths occurring in more developed countries and 57% occurring in the developing regions Ridge et al. . Non-small cell lung cancer (NSCLC) is the most commonly diagnosed type of lung cancer forming about 85% of all cases. It grows up and spreads much slowly than small cell lung cancer Barzi & Pennell . At diagnosis, more than 80% have locally advanced stage III or stage IV tumor and are not candidate for curative surgery. Five year survival is less than 10% in this patient population Treat et al. . The one year survival rate for lung cancer increased from 35% in between 1975 and 1979 to 42% in 1988 up to 2008. Five year survival rate for lung cancer is poor. The overall 5-year survival rate for lung cancer of all stages was 16.8% in 2004 and increased
slightly over time, in comparison with a 13.3% 5-year survival
rate in 1982 Ridge et al. .
Measures for treatment in NSCLC include: surgical resection,
radiotherapy, chemotherapy and targeted therapy. They can
be used as solo modality or in combination depending on the
disease status Ravenel . Treatment options for resectable
locally advanced NSCLC include radical chemo-radiotherapy and
induction neo-adjuvant therapy followed by surgery Thomas
et al. . Combination chemotherapy is the standard of care
for patients with locally advanced non-resectable NSCLC and
a performance status score of 0 or 1 Ramalingam & Belani
. Taxanes as paclitaxel and docetaxel are important classes
of chemotherapeutic agents McGrogan et al. . The aim of
our retrospective study is to evaluate the role of taxol based
chemotherapy in treatment of non-metastatic NSCLC in the term
of response rate (RR) and toxic profile then to assess progression
free survival (PFS) and overall survival (OS).
Adequate bone marrow, liver, and kidney functions
(haemoglobin ≥ 9g/dl, platelet ≥100,000/l, WBCs ≥3000/l
provided that absolute neutrophil count (ANC) ≥1500/l and
serum creatinine ≤1.5 upper limit of normal).
No prior treatment with chemotherapy.
This study was approved by the Ethical Committee of
Faculty of Medicine, Mansoura University. The collected data
from patient’s sheets included the history from all patients
as age, sex and smoking habit. General examination was done
including weight, height and surface area. Performance status
was assessed according to Eastern Cooperative Oncology
Group (ECOG). Tumor staging for all patients were documented
according to TNM staging system. Investigations included
pathological, radiological and laboratory investigations.
Thirty five patients were included in this study. The patients
received paclitaxel containing regimens. All were combined
either with carboplatin (33 patients) or with cisplatin (2
patients). In most of patients the schedule of paclitaxel used
was ranged from 175 -200 mg/m2 IV infusion over 3 h every
3weeks ,only 4 patients received paclitaxel 75 mg/m2 IV infusion
weekly. The number of cycles ranged from 4 to 8 and the median
number was 6. All patients were received pre-medications as recommended. Symptoms and signs of toxicities were assessed
either hematological toxicities or non-hematological toxicities.
Toxicities were reported according to the Common Terminology
Criteria for Adverse Events (NCI-CTCAE) version 4.0. The
primary end point in our research was to assess the RR and the
toxic profile and the secondary end points were to assess PFS
The data was collected, coded, processed and analyzed
using SPSS (statistical package for social sciences) version 16.
Qualitative data were described using number and percent.
Associations between categorical variables were tested using
Chi-square test (c2). Monte Carlo test was used whenever there
was one or more cell counted 5 or less. Continuous variables
were presented as mean ± SD (standard deviation) and Median
(min – max). The two groups were compared with Student t test
(parametric data) P-value considered significant if ≤ 0.05. The
survival functions were tested using Kaplan-Meier.
Between January 2008 and December 2013, thirty five
patients with newly diagnosed, non- metastatic NSCLC were
included for this analysis. Patient’s characteristics and tumors
features were mentioned in Table 1. As regard response rate
only one patient (3%) achieved complete response (CR), partial
response (PR) was detected in 18 patients (51.5%), stationary
disease (SD) was demonstrated in 12 patients (34 %) and 4
patients (11.5%) had progressive disease as summarized in
Table 2. The most common toxicity was the hematological
toxicity. Leucopenia was detected in 5 patients (14%); (grade
I was 5.7 %), (grade II was 5.7 %), and (grade III was 2.8 %).
Thrombocytopenia was found only in one patient (2.8%) and was
grade I. Three patients (8.5%) developed anemia during therapy,
2 patients (5.7 %) was grade I anemia and 1 patient (2.8%) was
grade II. Other adverse effects as peripheral neuropathy was
observed in 3 patients (8.5%), grade I was in one patient and
grade II was detected in 2 patients (5.7 %). Two patients (5.7
%) suffered from grade II emesis. Also diarrhea was noticed in 2
patients (5.7 %). Less common toxicities were observed as rising
serum creatinine as shown in Table 3. Survival analysis was
done for this study showed that median PFS was 8 months (95%
Confidence Interval, 6.774 -9.226 months) as shown in Figure
1. The median OS was 13 months (95% Confidence Interval,
10.533 –15.467 months) as shown in Figure 2.
Our study was a retrospective study included 35 patients
with non-metastatic NSCLC received taxol based chemotherapy.
It showed male predominance 57% and female percentage was
43% in comparable to the study of Liao WY et al.  at 2013
with male 52% and female percentage48% Liao et al. . In our
study 94 % of patients had stage III disease. Complete response
(CR) was achieved in one patient(3%) and 20 patient (51.5 %)
showed partial response (PR) with overall response rate (ORR)
(54.5%) , while Kocher F and his colleagues at 2014 evaluated
response after induction of docetaxeland cisplatin in 78 chemonaïve
patients with NSCLC stage II, IIIA and IIIB. Partial response
to induction therapy was observed in 43 patients (55%) Kocher
et al. . Liao WY and his colleagues at 2013demonstrated the
efficacy of taxanes among 62 patients with stage III N2 NCSLC,
CR was detected in one patient (2%) and PR was achieved in 25
patients (40%) with ORR (42%) Liao et al. . Other studies as
Chen YM et al. , Stathopoulos GP et al. , Inoue A et al. 
showed ORR 40%, 42.86%, 45% respectively. This difference
could be attributed to larger sample size in other studies.
The median OS in our study was 13 months (95% Confidence
Interval, 10.533 -15.467 months) which cope with Bonomi P et
al.  results. Their study included 599 patients to Compare OS
and life quality in advanced non-small-cell lung cancer patients
treated paclitaxel combined with cisplatin versus etoposide
with cisplatin. The median survival duration for the stage IIIB
subgroup in paclitaxel arm was13.1 months. A randomized
phase II study compare weekly paclitaxel versus vinorelbine in
combination with cisplatin against inoperable chemo-naïvenonsmall-
cell lung cancer included 140 patients.
The median survival time was 11.7 months in the paclitaxelcisplatin
arm Y Chen et al. . Also the results obtained in our
series are better than Fossella F et al. , Sandler A et al. ,
Lynch TJ et al.  and Zhu J et al.  with OS 11.3, 10.3, 8.38
, 8.9 months respectively. This difference could be attributed to
larger sample size in these studies; also these studies included
stage III and IV disease, so their OS lower than the OS in our
study. Regarding PFS in our study was 8 months and were higher
than Chen YM et al. , Mok TS et al. , Mitsudomi T et al.
 and Niho S et al.  that reported median PFS of 6, 5.8, 6.3,
5.9 months respectively.
The commonest toxicity in our study was the hematological
toxicity. Other adverse effects as peripheral neuropathy was
observed in 3 patients (7.5%), 2 patients (5%) suffered from
grade II emesis and diarrhea was noticed in 2 patients (5%)
only. On the other hand; Kosmidis P et al.  demonstrated
mild toxicities in paclitaxel and carboplatin combinations for
the treatment of advanced non-small-cell lung cancer. Grades ¾
neutropenia, thrombocytopenia, and anemia were seen in (15%)
and (15%), (2%) respectively Kosmidis et al. . Inoue A et
al.  assessed toxicities of weekly paclitaxel combined with
carboplatin in elderly patients with advanced NSCLC.
The most Common toxicities were hematological; Grades ¾
leucopenia, thrombocytopenia, and anemia were observed in
(30%), (15%), (13%) respectively, while peripheral neuropathy
and nausea were detected only in 3% of patients. The higher
hematological toxicities in this study could be explained by
the old age that may be liable for more adverse events Inoue et
al. . Scagliotti GV and his colleagues reported at 2010 the
adverse effects of carboplatin and paclitaxel in chemotherapynaïve
patients with advanced NSCLC. Neutropenia was 7%,
thrombocytopenia was 3%, Anemia was 9%, peripheral
neuropathy was 13%, vomiting was 7%, diarrhea was 13 % and
oral mucositis was 2% Scagliotti et al. .
In conclusion in our study; taxol are active class of
chemotherapeutic agents in NSCLC and well tolerated. This agent
exhibit clinical differences that can affect the choice of agents.
However, further studies with longer follow up are needed for
better orientation and comparisons with other agents.