Journal of Clinical and Diagnostic Research, ISSN - 0973 - 709X

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MBBS, MD (Pathology),
Sanjay Gandhi institute of trauma and orthopedics,
Bengaluru.
On Aug 2018




Dr. Mamta Gupta,
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Dr. Mamta Gupta
Consultant
(Ex HOD Obs &Gynae, Hindu Rao Hospital and associated NDMC Medical College, Delhi)
Aug 2018




Dr. Rajendra Kumar Ghritlaharey

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Thanking you
With sincere regards
Dr. Rajendra Kumar Ghritlaharey, M.S., M. Ch., FAIS
Associate Professor,
Department of Paediatric Surgery, Gandhi Medical College & Associated
Kamla Nehru & Hamidia Hospitals Bhopal, Madhya Pradesh 462 001 (India)
E-mail: drrajendrak1@rediffmail.com
On May 11,2011




Dr. Shankar P.R.

"On looking back through my Gmail archives after being requested by the journal to write a short editorial about my experiences of publishing with the Journal of Clinical and Diagnostic Research (JCDR), I came across an e-mail from Dr. Hemant Jain, Editor, in March 2007, which introduced the new electronic journal. The main features of the journal which were outlined in the e-mail were extensive author support, cash rewards, the peer review process, and other salient features of the journal.
Over a span of over four years, we (I and my colleagues) have published around 25 articles in the journal. In this editorial, I plan to briefly discuss my experiences of publishing with JCDR and the strengths of the journal and to finally address the areas for improvement.
My experiences of publishing with JCDR: Overall, my experiences of publishing withJCDR have been positive. The best point about the journal is that it responds to queries from the author. This may seem to be simple and not too much to ask for, but unfortunately, many journals in the subcontinent and from many developing countries do not respond or they respond with a long delay to the queries from the authors 1. The reasons could be many, including lack of optimal secretarial and other support. Another problem with many journals is the slowness of the review process. Editorial processing and peer review can take anywhere between a year to two years with some journals. Also, some journals do not keep the contributors informed about the progress of the review process. Due to the long review process, the articles can lose their relevance and topicality. A major benefit with JCDR is the timeliness and promptness of its response. In Dr Jain's e-mail which was sent to me in 2007, before the introduction of the Pre-publishing system, he had stated that he had received my submission and that he would get back to me within seven days and he did!
Most of the manuscripts are published within 3 to 4 months of their submission if they are found to be suitable after the review process. JCDR is published bimonthly and the accepted articles were usually published in the next issue. Recently, due to the increased volume of the submissions, the review process has become slower and it ?? Section can take from 4 to 6 months for the articles to be reviewed. The journal has an extensive author support system and it has recently introduced a paid expedited review process. The journal also mentions the average time for processing the manuscript under different submission systems - regular submission and expedited review.
Strengths of the journal: The journal has an online first facility in which the accepted manuscripts may be published on the website before being included in a regular issue of the journal. This cuts down the time between their acceptance and the publication. The journal is indexed in many databases, though not in PubMed. The editorial board should now take steps to index the journal in PubMed. The journal has a system of notifying readers through e-mail when a new issue is released. Also, the articles are available in both the HTML and the PDF formats. I especially like the new and colorful page format of the journal. Also, the access statistics of the articles are available. The prepublication and the manuscript tracking system are also helpful for the authors.
Areas for improvement: In certain cases, I felt that the peer review process of the manuscripts was not up to international standards and that it should be strengthened. Also, the number of manuscripts in an issue is high and it may be difficult for readers to go through all of them. The journal can consider tightening of the peer review process and increasing the quality standards for the acceptance of the manuscripts. I faced occasional problems with the online manuscript submission (Pre-publishing) system, which have to be addressed.
Overall, the publishing process with JCDR has been smooth, quick and relatively hassle free and I can recommend other authors to consider the journal as an outlet for their work."



Dr. P. Ravi Shankar
KIST Medical College, P.O. Box 14142, Kathmandu, Nepal.
E-mail: ravi.dr.shankar@gmail.com
On April 2011
Anuradha

Dear team JCDR, I would like to thank you for the very professional and polite service provided by everyone at JCDR. While i have been in the field of writing and editing for sometime, this has been my first attempt in publishing a scientific paper.Thank you for hand-holding me through the process.


Dr. Anuradha
E-mail: anuradha2nittur@gmail.com
On Jan 2020

Important Notice

Original article / research
Year : 2008 | Month : August | Volume : 2 | Issue : 4 | Page : 946 - 951

A Comparative Clinical Study of the Docetaxel-Carboplatin combination and the Gemcitabine- Carboplatin combination in Patients with Non Small Cell Lung Cancer

SUMANTH M *, PHILIPJ **, RADHESHYAM*** ULLA I ****

** &**** Department of Pharmacology,Visveswarapura Institute of Pharmaceutical Sciences,Banshankari IInd stage, Bangalore-560070(India)*** Medical Head,Curie centre of Oncology,St. Johns Medical college campus, Koramangala,Bangalore-560044 (India)

Correspondence Address :
Sumanth M Department of Pharmacology, Visveswarapura Institute of
Pharmaceutical Sciences,
Banshankari IInd stage, Bangalore-560070 (India)Email:meerasumanth@gmail.com

Abstract

Back Ground: Non small cell lung cancer (NSCLC) constitutes about 75-80% of all lung cancer cases. In the chemotherapy of NSCLC, a platinum drug can be combined with taxanes or Gemcitabine.
Aim: To compare the Docetaxel-Carboplatin (DC) and Gemcitabine-Carboplatin (GC) treatment regimen in patients with NSCLC.
Setting And Design: Prospective, Randomized, Open labeled double arm study
Methods: Thirty patients with stage IIIB/IV NSCLC were randomly divided into two groups. The patients of the DC group were treated with Docetaxel (75 mg/m2, day one) and Carboplatin (calculated to give an AUC of 6 mg/ml, day one) and those of the GC group were treated with Gemcitabine (1200 mg/m2, day one and eight) and Carboplatin (day one). Treatment cycles were repeated every 21 days for a period of three cycles. Response and toxicity were assessed using WHO criteria.
Results: The patients in both the groups were well balanced for demographics and disease. Objective responses were similar in the two groups; DC group: 20% partial response, 60% stable disease and 20% of progressive disease. GC group: 33.3% partial response, 53.3% stable disease and 13.3% progressive disease. The only significant toxicity was anemia in the DC group. The evaluation of the quality of life of patients in both the groups showed significant change in the incidence of anemia, dysphagia and peripheral neuropathy in the DC group. Alopecia was significantly higher among the patients of the GC group.
Conclusion: The toxicity profiles of the Docetaxel-Carboplatin and Gemcitabine- Carboplatin combinations were similar. The Docetaxel-Carboplatin treatment regimen is cost effective for patients. Global quality of health is not improved in either combination, although advantages in some components of ten QOL were apparent.

Keywords

Non small cell lung cancer (NSCLC), Docetaxel, Gemcitabine, Carboplatin, Quality of life, tumour response, haematology.

Introduction
Uncontrolled multiplication and spread of abnormal forms of cells within the body is termed as Cancer. It is one of the major causes of death in the developed nations (1). Lung cancer has a death rate, greater than that attributed to colorectal, breast and prostate cancers combined (2).Non small cell lung cancer (NSCLC) constitutes about 75-80% of all lung cancer cases, and accounts for 1.2 million cases world wide each year(3). The role of platinum-based chemotherapy has now been clearly established in advanced stage NSCLC. Chemotherapy improves survival rate in patients with stage IV disease as compared to best supportive care, in patients with inoperable stage III, when combined with thoracic radiation and compared to radiation alone. Chemotherapy improves survival rate in patients with stage IIIA (N2) also, when given before radical surgery as compared to surgery alone (3). One of the chemotherapeutic treatments of NSCLC is, combining a platinum agent with one of the two taxanes (Docetaxel, Paclitaxel), vinorelbine or gemcitabine(4). The possible haematological and non haematological toxicities of these treatments include anemia, neutropenia, thrombocytopenia, nausea/vomiting, mild skin rash, diarrohea, mucositosis, constipation, neurotoxocity, asthenia, neutropenia, fluid retention, asthenia, alopecia, hypersensitivity reactions, and skin and nail toxicities (5),(6).

The assessment of a cancer patient broadly includes two sets of endpoints - cancer outcome and patient outcome. Cancer outcome measures the response of a patient to treatment, duration of response, symptom free period, and early recognition of relapse. Patient outcome, on the other hand, assesses the survival benefit attained after treatment as measured by the increase in life span, and the quality of life before and after therapy. Quality of life (QOL) is a broad, subjective, and multidimensional concept that includes: (a) Physical health and symptoms (b) Functional status and activities of daily living (7). The present study was taken up with the aim of comparing Docetaxel-Carboplatin and Gemcitabine-Carboplatin treatment regimens in patients with non small cell lung cancer.

Material and Methods

A prospective, randomized, open labeled, double-arm study of a total duration of eight months, was taken up from November 2006 to June 2007, at the Curie Centre of Oncology, St. Johns Medical College and Hospital campus, Bangalore. Thirty patients of NSCLC of both sexes with an age range of 35-65 years, from different strata of society, were included in the study. The institutional Ethics Committee¬Āfs permission was obtained before starting the studies.

Inclusion and exclusion criteria
Patients suffering from cytologically or histologically confirmed stage III/IVB non small cell carcinoma, with no prior chemotherapy treatment given, were included in this study. Patients having a WHO performance status of <3 and adequate liver, kidney and bone marrow functions, were included in the study. All patients signed informed consent before enrollment into the study.

Patients with active infection, symptomatic central nervous system metastases, pregnancy, second primary malignancy, or serious concomitant systemic disorders, inadequate liver function (bilirubin >1.5 times upper limit of normal), with alanine transaminase or aspartate transaminase less than three times normal or inadequate renal function, HIV/HbSAg +ve, or with life threatening systemic diseases were excluded from the study.

Treatment Regimen
Hospitalized patients were centrally randomized according to age, performance status and stage of disease to receive either Docetaxel-Carboplatin (DC group) or Gemcitabine-Carboplatin (GC group) treatment. DC group patients received Docetaxel 75 mg/ m2 as a one-hour i.v. infusion, immediately followed by, Carboplatin, calculated to give an AUC of 6 mg.min/ml according to the Calvert formula. The GC group patients received 1200 mg/m2 Gemcitabine intravenously over 30 minutes on days one and eight, and Carboplatin on day one. Standard WHO toxicity and response criteria were used. To access the toxicity during treatment, differential leucocyte count and platelet count were done weekly. In the event of grade three or four neutropenia, febrile neutropenia, or grade four thrombocytopenia, the complete blood-cell count was done daily until the absolute granulocyte count was greater than 1200/∆í√äL and the platelet count was greater than 50¬Ā~103/∆í√äL. A detailed medical history was recorded, and a complete physical examination was done before each course of treatment, to assess symptoms of the disease and treatment toxicity. Biochemical tests, electrocardiogram and chest radiographs were done at the beginning of the Ist course and after completion of the IIIrd course.

The quality of life (QOL) was assessed with the English or Kannada version of EORTC QLQ-C30 and QLQ-LC 13 questionnaires. The patients answered the questionnaire before and during the treatment. QOL scores were assessed according to the EORTC-QLQ scoring manual. The scores were transferred to a scale of 0 to 100. A high score for a functional or global QOL scale represents a relatively high/healthy level of functioning or global quality of life, whereas a high score for a symptom scale represents the presence of a symptom or problem(s).

Statistical Analysis
Values were expressed as mean ¬Ā} SEM or as percentages, and were analyzed using the Fisher exact test. The quality of life questionnaires were analyzed by the Wilcoxon signed rank test.

Results

Demographics of the thirty patients (15 patients each in both the groups) enrolled in the study are shown in (Table/Fig 1), which indicates that incidence of NSCLC is less in females.

Toxicity
As shown in (Table/Fig 2), incidence of anaemia was statistically significant (P=0.065) in patients treated with the DC combination as compared to patients treated with the GC combination. Incidence of neutropenia, leucopenia, nausea/vomiting and alopecia, was higher in patients treated with the GC combination than in those treated with the DC combination, while incidence of thrombocytopenia and diarrohoea was slightly higher in patients treated with DC combination.

Response
As shown in (Table/Fig 3), incidence of partial response and progressive disease was seen more in the GC group, and the incidence of stable disease was more in the DC group. On comparison of the tumour size pre and post chemotherapy, no significant difference was seen between the DC group (P= 0.078) and the GC group (P=0.070)

QOL
As shown in (Table/Fig 4)and(Table/Fig 5), the functional scale of patients treated with the DC combination showed a decline in the physical and social functioning, while the patients treated with GC combination showed a decline in role, emotional and cognitive functioning.

When the symptom scales of patients were assessed using the EORTC QLQ-LC13 questionnaire, it was found that incidence of dysphagia and peripheral neuropathy was significantly more in the patients treated with the DC combination. The incidence of alopecia significantly increased in the patients treated with the GC combination as seen in (Table/Fig 6) .


Discussion

New strategies are required in the treatment of NSCLC for clinically significant progress. The emergence of new generations of chemotherapeutic agents with anticancer activity in NSCLC, has generated interest in the development of platinum based treatment regimens. Various studies have substantiated the combined use of Docetaxel-Carboplatin and Gemcitabine-Carboplatin (8),(9).

The present clinical study indicates a higher incidence of NSCLC in males. This may be due to various reasons like smoking, occupational hazards etc. The toxicity profiles of the DC and GC regimens are similar. Patients treated with the DC regimen showed a higher incidence of anemia, whereas nausea/vomiting was severe in the patients treated with the GC arm. These toxicities may be due to the platinum based drug, Carboplatin, as indicated by a randomized study (10) conducted by some scientist, earlier. It is also reported that carboplatin-based chemotherapy develops the risk of grade 3 or 4 thrombocytopenia, anemia, neutropenia and neurotoxicity (11).

QOL
Platinum based chemotherapy regimens are the standard treatment for patients with NSCLC. The present clinical study is the first of its kind, which attempts to assess the QOL of NSCLC patients treated with the GC and DC combination regimens using EORTC guidelines. The results showed that there was no significant improvement in the quality of life of patients treated with either regimen. The incidence of alopecia was significantly increased in the patients treated with the GC regimen, and the incidence of dysphagia and peripheral neuropathy was significant in the patients treated with the DC regimen. There was no significant advantage of either of the treatment arm over the other, but for cost effectiveness.

Cost Effectiveness of the Treatment
The cost of the GC combination treatment regimen for a patient of NSCLC for three treatment cycles is in the range of Rs. 45,500-66,780. The cost of the DC combination treatment regimen for a patient of NSCLC after three treatment cycles is about of Rs. 43,500. It is evident that from the patient¬Āfs point of view, the DC combination treatment regimen is cost effective. Also, it is interesting to note that there is no significant advantage of the gemcitabine treatment over the docetaxel treatment regimen (12).

Conclusion

Both the DC and GC combination regimens are effective in the treatment of NSCLC. The toxicities due to both drug combinations are similar. The global quality of health is not improved by either combination.
From the patient¬Āfs point of view, the DC combination treatment regimen is cost effective.

Limitation of the Study
Because of the short term nature of study, survival rate, time to progressive disease and response duration could not be evaluated. Emphasis was given to the tumour response, toxicity profiles and quality of life of the patients.

Suggestion to Oncologists
Since the toxicity profile of the both the combinations is the same, and the DC combination being cost effective, it may be recommended that the DC (Docetaxel-Carboplatin) combination is a better treatment option as compared to the GC (Gemcitabine-Carboplatin) combination, to treat NSCLC.

References

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Rang HP, Dale MM, Ritter JM, Moore PK. In: Pharmacology, 5th edition, London: Churchill livingstone publications; 2003;50:PP693
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O¬Āfbrien MER, Szczesna A, Karnicka H, Zatloukal P, EIsen T, Hartmann W, et. al. Vinorelbine alternating oral and intravaenous plus Carboplatin in advanced non small cell lung cancer: results of a multi centre phase II study. Ann Oncol 2004;15(6):921-7
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Tiseo M, Franciosi V, Grossi F and Ardizonni F. Adjuvant chemotherapy for non-small cell lung cancer: Ready for clinical practice? Eur J Cancer 2006; 42(1):8-16.)
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Rogerio L. Options in Advanced Non-Small Cell Lung Cancer: A Review and Report on a Phase II Study of Vinorelbine plus Gemcitabine. Oncologist 2001; 6(l 1):16-9.
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Evans WK. Rationale for the treatment of NSCLC. Lung Cancer 1993;9:5-14
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Pasetto LM, D¬Āfandrea MR, Falci C, Monfardini S. Gemcitabine in advanced biliary tract cancers. Crit Rev Oncol 2007;61(3):230-42
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Mohan A, Randeep G, Pathak AK, Manisha B, Pal Hemraj, Mohan C,et.al. Quality of life measures in lung cancer. Indian J Pharmacol 2005;42(3):125-32
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Barlesi F, Doddoli C, Loundou A, Pillet E, Thomas P, Auquier P. Preoperative psychological global well being index (PGWBI) predicts postoperative quality of life for patients with non-small cell lung cancer managed with thoracic surgery. European Journal of Cardio-Thoracic Surgery 2006;30(3):548-53
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Kelly K, Kamel MN, Pan X, Murphy J, Prindiville S and Bunn PA, Jr.A Phase I/II Trial of Paclitaxel, Carboplatin, and Gemcitabine in Untreated Patients with Advanced Non-Small Cell Lung Cancer. Clin Cancer Res 2000;6:3474-79
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Georgoulias V, Papadakis E, Alexopoulos A, Tsiafaki X, Rapti A, Veslemes M, Palamidas, et al. Platinum-based and non-platinum-based chemotherapy in advanced non-small-cell lung cancer: A randomized multicentre trial. Lancet 2001; 357(9267):1478-84.
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Jiang J, Liang X, Zhou X, Huang R, Chu Z., A meta-analysis of randomized controlled trials comparing carboplatin-based to cisplatin-based chemotherapy in advanced non-small cell lung cancer. Lung Cancer 2007; 57(3):348-58
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Leong Swan Swan, Toh, Chee Keong ,Lim, Wan Teck, Lin, Xu Tan, Say Beng , Poon Donald ,Tay Miah Hiang ,Foo Kian Fong , HoJuliana Tan Eng Huat. A Randomized Phase II Trial of Single-Agent Gemcitabine, Vinorelbine, or Docetaxel in Patients with Advanced Non-small Cell Lung Cancer Who Have Poor Performance Status and/or Are Elderly. J. of Thoracic Oncology. 2007; 2(3):230-36

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  • Journal seek Database
  • Google
  • Popline (reproductive health literature)
  • www.omnimedicalsearch.com