Journal of Cancer Research and Therapeutics CONTENTS

Journal of Cancer Research and Therapeutics
January-March 2008 | Volume 4 | Issue 1
CONTENTS
Editorial
Criteria for deciding cost-effectiveness for expensive new anti-cancer agents
Rajiv Sarin .............................................................................................................................................................1
Original Articles
The effect of three mouthwashes on radiation-induced oral mucositis in patients with head
and neck malignancies: A randomized control trial
PD Kumar Madan, PS Sequeira, Kamalaksha Shenoy, Jayaram Shetty .............................................................3
Implications of contrast-enhanced CT-based and MRI-based target volume delineations in
radiotherapy treatment planning for brain tumors
Niloy R Datta, Rajasekar David, Rakesh K Gupta, Punita Lal ..............................................................................9
Radiofrequency ablation of hepatic metastasis: Results of treatment in forty patients
GK Rath, PK Julka, S Thulkar, DN Sharma, Amit Bahl, S Bhatnagar.................................................................14
Execution of mantle field with multileaf collimator: A simple approach
Ramachandran Prabhakar, Kunhi Parambath P Haresh, Pappiah S Sridhar, Macharla A Laviraj,
Pramod K Julka, Goura K Rath ...........................................................................................................................18
Prognostic and diagnostic value of serum pseudocholinesterase, serum aspartate
transaminase, and serum alinine transaminase in malignancies treated by radiotherapy
Arun Chougule, Sofia Hussain, Dwaraka Prasad Agarwal .................................................................................21
Review Article
An overview on applications of optical spectroscopy in cervical cancers
C Murali Krishna, GD Sockalingum, MS Vidyasagar, M Manfait, Donald J Fernanades, BM Vadhiraja,
K Maheedhar.......................................................................................................................................................26
Case Reports
Radiotherapy for management of skin cancers in fibrodysplasia ossificans progressiva:
A case report and review of the literature
John Antony Frew, Charles G Kelly ....................................................................................................................37
Sarcomatoid squamous cell carcinoma of uterine cervix: Pathology, imaging, and treatment
Milind Kumar, Amit Bahl, Daya Nand Sharma, Shipra Agarwal, Dhanapathi Halanaik, Rakesh Kumar,
Goura Kishore Rath ............................................................................................................................................39
Brief Communications
Chest wall metastasis from hepatocellular carcinoma in the absence of a primary: An unusual
presentation
Kaustav Talapatra, Reena Engineer, Jai Prakash Agarwal, Shilpa Vyas, Shyam Kishore Shrivastava .............42
Endobronchial metastasis of follicular thyroid carcinoma presenting as hemoptysis: A case report
RAS Kushwaha, Sanjay Kumar Verma, Sanjay Vineet Mahajan ........................................................................44
Accelerated partial breast irradiation: An advanced form of hypofractionation
Ashwini Budrukkar ..............................................................................................................................................46
Coexistence of carcinoma breast and Paget’s disease of bone
S Sundaraiya, PK Pradhan, A Gupta, M Jain, SK Mishra, BK Das.....................................................................48
Letter to Editor
Dysplastic hematopoiesis and underlying dysthyroidism
Riad Akoum, Michel Saade, Wafic Tabbara, Emile Brihi, Marwan Masri, Khaled Habib, Gerard Abadjian ........50
Reviewers’ List, 2007 ..............................................................................................................................51
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J Cancer Res Ther - March 2008 - Volume 4 - Issue 1
53
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Editorial
Criteria for deciding cost-effectiveness for
expensive new anti-cancer agents
Containing the spiralling cost of modern cancer care
with its repertoire of targeted anti-cancer biological
agents and the technological breakthroughs has
become a matter of great concern worldwide.
Targeted therapies are hailed as breakthroughs in
science and medicine, offer new hope for desperate
cancer patients and also present huge commercial
opportunities for the industry. However, there is a
growing tussle between the beneficiaries of these
breakthroughs (cancer patients and industry) and
those who decide how public funds allocated
for healthcare should be used in a judicious and
equitable manner. The root cause of this tussle is
the projected and perceived degree and duration of
clinical benefit with newer agents and the economic
implications for providing these treatments. At the
two extremes of this tussle, the drug rationing
authorities are projected as being slow and
sometimes insensitive to the suffering of cancer
victims while the industry is accused of being
opportunistic or even unethical, as exemplified by
the unfolding story of erythropoietin with sales of
over 10 billion US$ annually.
Most new targeted biological therapies developed
for cancer are required to be given for 6-12 months
and sometimes longer until the response lasts. With
the exception of certain biological agents where
more economical generics are available in some
countries like India, the cost of the entire course of
these new drugs range from 10,000 to 100,000 US$.
While a few of these new molecules can increase
cure rates of some cancers, the most common use
of these newer agents is in advanced disseminated
cancers where the clinical benefit is either symptom
relief or a very modest prolongation in life, often
measured in months. It is therefore not surprising
that several governments and health authorities
around the world have evolved elaborate methods
to critically evaluate the evidence for the clinical
benefit of new molecules before recommending
their provision using public funds. As expected,
any form of drug rationing is detested by patients
who feel that they are being denied their right to
get free access to the latest medicines, and also by
their doctors who feel handicapped by not being
J Cancer Res Ther - March 2008 - Volume 4 - Issue 1
able to offer the latest and the best drug to their
patients for some macro-economic reason.
Sir Michael Rawlins, Chairman of the UK National
Institute for Health & Clinical Excellence (NICE), in
his recent keynote comment in Lancet Oncology
titled “Paying for Modern Cancer Care - A Global
Perspective”, examines this very complex issue of
‘how the health care systems will judge affordability
of these products in the face of finite resources and
competing demands from other patients’. For
cancer, NICE has published appraisals for 36 drugclinical indication pairs. They used the notion of
incremental cost-effectiveness ratio (ICER) as the
additional cost for gaining one year of life. When
quality of life data was available the parameter
used was the quality of life-year gained. Thus, if
the use of a new targeted therapy in a particular
metastatic cancer increased the median survival by
3 months at an additional cost of 5,000 US$, the
ICER would be 20,000 US$ per life-year gained. Sir
Rawlins admits that there is no reliable empirical
basis for deciding cost-effectiveness thresholds
and that NICE uses the collective judgement of its
health economics advisor. If NICE was to accept
and recommend new treatments with ICER of
above 48,600 US$ per quality-adjusted life-year
gained, it would result in an opportunity cost,
i.e. displacement of other more cost-effective
healthcare programmes. Using these criteria, NICE
considers use of Bevacizumab or Cetuximab for
metastatic colorectal cancer and Fludarabine for
CLL as cost-ineffective in the UK, implying that the
manufacturers were asking too high a price for the
benefits the products conferred.
Rajiv Sarin
Radiation Oncology and
I/C Cancer Genetics Unit,
Director, ACTREC,
Tata Memorial Centre,
Navi Mumbai - 410 210,
India
For correspondence:
Prof. Rajiv Sarin,
Radiation Oncology and
I/C Cancer Genetics Unit,
Director, ACTREC,
Tata Memorial Centre,
Navi Mumbai - 410 210,
India. E-mail: rsarin@
actrec.gov.in
The World Health Organization (WHO) has
recommended that the per-capita Gross Domestic
Product, adjusted for the purchase power parity
of the country can be used for setting thresholds
for cost-effectiveness in different countries. Thus,
interventions for which the additional cost incurred
to gain one quality-adjusted life year is less than
the country’s per-capita GDP are considered as
very cost-effective, those between 1 and 3 times
the per-capita GDP as cost-effective and those
1
Sarin: Criteria for cost effectiveness
with an additional cost of over three times per-capita GDP
as cost-ineffective. Using this WHO criterion, Sir Rawlins
has estimated that the vast majority of the 26 pairs of new
drugs-clinical conditions in cancer would be considered as
cost-ineffective for most countries in South Asia and Asia
Pacific Region.
The per-capita GDP of India using the Purchase Power Parity
figures of the World Bank is 3,800 US$. Using the present
exchange rate of 40 Indian Rupees to a US Dollar, if the cost of
gaining one quality-adjusted life year with a treatment is up
to Rs. 1,50,000 it would be considered as very cost-effective,
if it is between Rs. 1,50,000 and Rs. 4,50,000 it would still be
considered as cost-effective, but if it is over Rs. 4,50,000 the
intervention would be considered as cost-ineffective. In India,
the Working Group on Drugs and Pharmaceuticals for the
eleventh five-year plan (2007-12) in its report to the Planning
Commission has highlighted the need for ‘Provision for Price
and availability of Cancer medicines Fund’ as one of the seven
important measures for the welfare of the common man.
The health authorities, government organizations and other
reimbursing agencies in the developing world are yet to
establish the elaborate machinery required to systematically
evaluate the clinical benefit of any new expensive treatment
2
and decide whether it would be cost-effective to provide
them using the limited public funds. In the absence of any
definitive guidelines from national agencies in the developing
world, it is imperative that patient groups, ethicists,
clinicians, industry representatives and health economists
debate the pros and cons of rationing very expensive drugs
when paid for through public funds. In my opinion, the
WHO recommendations for judging cost-effectiveness as
outlined above would be a good beginning. It is inevitable
that several limitations of this approach would emerge when
it is implemented, and with time a better and truly equitable
system would emerge.
It was never easy for a clinician and the healthcare system
to come up to the expectation of a person with advanced
disseminated cancer, and such economic undercurrents could
only make it worse for all concerned. As much as we hate
rationing of drugs provided through public funds, it is a reality
that cannot be escaped. The best and the most logical solution
would be for the industry to realize that what it sells should be
good value for money in a holistic societal context and for the
life-saving drugs, the society should be in a position to make
it affordable to the majority of people who would benefit from
it. This may be rather optimistic, but at no cost we want the
argument to be lost to either numbers or sentiments.
J Cancer Res Ther - March 2008 - Volume 4 - Issue 1
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