Introduction Continued

• Treatments for NSCLC are chemotherapy,immunotherapy,photodynamic

therapy ,radiation therapy and surgery
• ADVANCED non-small-cell lung cancer (NSCLC) has a median survival
time of 6 to 8 months at best in most series, and a 1-year survival rate of
only 10% to 20%.
• Among the chemotherapy Cisplatin-containing chemotherapy regimens
have led to only marginal improvements in survival.
• In this paper the investigator was tried to study combination of paclitaxel
and carboplatin in phase II trial to determine toxicity and response &
survival time.

03/29/2022 By; Group-3 1

Objective of the study

Objective of the study is clearly stated

The objective of the study were
 To determine the activity and toxicity of Combination paclitaxel and
carboplatin in advanced non-small-cell lung cancer (NSCLC).

03/29/2022 By; Group-3 2

 Methodology (1/6)

Null hypothesis
 there is no difference in response rate & survival time of patients with NSCLC
who are taking combination of paclitaxel and carboplatin and
toxicity among patients with NSCLC who are taking combination of paclitaxel and
carboplatin.
Alternative hypothesis
There is difference in response rate & survival time among patients with NSCLC
who are taking combination of paclitaxel and carboplatin and
 toxicity among patients with NSCLC who are taking combination of paclitaxel
and carboplatin.

03/29/2022 By; Group-3 3

 Methodology (2/6)

The study has only treatment group

comparison group: there is no control group because the trial is phase II with the
purpose of assessing response/activity and toxicity .
so no need to have randomized control group.
treatment group: all subjects who are taking the same treatment which is
combination of paclitaxel with carboplatin
Study design
Phase II experimental trial design was applied

03/29/2022 By; Group-3 4

Methodology (3/6)

inclusion / exclusion criteria;

There were clearly specified inclusion and exclusion criteria
the criteria's were a subset of pre-specified event of interest.
 Patient over 18 years of age with chemotherapy-naive, histologically proven,
NSCLC that was recurrent, stage IV, or stage IIIB with malignant pleural effusion
 Patients with brain metastasis after treatment with brain radiation
 Stabilized ECOG performance status 0 or 1
 adequate hematologic parameters

03/29/2022 By; Group-3 5

Methodology (4/6)
Patients were excluded from the study if they have /are
 a history of prior unrelated malignancy in the antecedent 3 years, with the
exception of non-melanomatous skin cancer or in situ cervical or breast
carcinoma.
 Pregnant women
 completion of radiation or biologic therapy less than 4 weeks before initiation of
treatment
• mixed non-small-cell and small-cell histology
• previous radiation to greater than 30% of marrow-bearing bone

03/29/2022 By; Group-3 6

Methodology (4/6)

end points
efficacy end point
time to response, time to death (survival time) for 1 year among patients with
NSCLC who are taking combination of paclitaxel and carboplatin.
Safety end points
treatment related toxicity (percentage of patients develop Myelosuppression,non
hematologic toxicity )
Eg Granulocytopenia was most pronounced during the first cycle, during which
57% of patients sustained grade 3 or 4 toxicity.

03/29/2022 By; Group-3 7

Methodology (5/6)

Sample size
The calculated sample size were adequate(54)
Because phase II trial needs 15- 50 patients
Statistical analysis
• Event-free survival and overall survival were estimated using the method of
Kaplan and Meier.
• Since the investigator interested to determine one year survival after treatment
he/she uses the non parametric survival analysis.
• Confidence bounds on response rates were the usual large-sample estimates for
the binomial distribution were used.

03/29/2022 By; Group-3 8

Result

The report of result was good .Because

It presents the descriptive results by using different methods . i.e. text, table and
figures.
Kaplan Meir curve with the corresponding confidence interval were presented
It also reports the analytic result according to their plan
Efficacy (response and survival) and toxicity results are better reported separately
and in detail.
Their interpretation was good with detail discussions for their plan/objective and
analysis result.

03/29/2022 By; Group-3 9

Acknowledgment

Our depest gratitude goes to

 Dr. Bedilu A. who gave us this project that help us to get deep underatanding
and plenty of knowledge on the topics given.
Secondly , to the University of Gondar for its good ICT infrastructure that enable
us to search different materials for the project.

03/29/2022 By; Group-3 10

 Thank you

03/29/2022 By; Group-3 11