Pancreatic Cancer: Highlights from the 42

Muhammad Wasif Saif
Yale University School of Medicine. New Haven, CT, USA
ABSTRACT
Despite advances in our understanding of the
molecular and genetic basis of pancreatic
cancer, the disease remains a clinical
challenge. Gemcitabine, the standard
chemotherapy for pancreatic cancer, offers
modest improvement of tumor-related
symptoms and marginal advantage of
survival. New approaches, alone and in
combination with gemcitabine, are being
developed to combat this cancer.
Combination
chemotherapy
trials
incorporating gemcitabine, cisplatin, 5-
fluorouracil, oxaliplatin, or irinotecan
generally show improved outcomes in
objective response rates but with little or no
improvement in survival in phase III trials. In
this article, the author describes the key
studies presented at the Annual Meeting of
ASCO, held in Atlanta, GA from June 2
nd
to
6
th
. The studies discussed here include the
following: RTOG 9704 (#4007), FFCD-
SFRO study (#4008), meta-analysis of
gemcitabine plus cisplatin and gemcitabine
plus oxaliplatin vs. gemcitabine alone
(GERCOR #4003), and ECOG 6201 (Late
Breaking Abstract #4004). Based on the
results presented at the annual meeting, it
comes to us that patients with locally
advanced vs. metastatic pancreatic cancer
should be studied separately, better
understanding of the biology of pancreatic
cancer is mandatory and evaluation of novel
agents is crucial. We as oncologist have to
change our attitudes towards clinical trials
and need to think beyond a trial design such
as gemcitabine vs. drug of our choice.
Environment within which research is being
conducted also has to be changed and last but
not the least, access to trials for patients with
pancreatic cancer is the key step in the fight
against pancreatic cancer.
Adenocarcinoma of the pancreas is the fourth
leading cause of cancer death in the United
States. According to the American Cancer
Society, the 1-year relative survival rate is
only 20% and 5-year survival only 4% for all
stages combined. Over the years, a number of
chemotherapy doublets have been evaluated
without significantly improving survival, thus
leaving single-agent gemcitabine as the
standard of care for the treatment of this
disease.
Despite advances in our understanding of the
molecular and genetic basis of pancreatic
cancer, the disease remains a clinical
challenge. Gemcitabine, the standard
chemotherapy for pancreatic cancer, offers
modest improvement of tumor-related
symptoms and marginal advantage of
survival. New approaches, alone and in
combination with gemcitabine, are being
developed to combat this cancer. In this
article, the author describes the key studies
presented at the annual meeting of ASCO,
held in Atlanta, GA from June 2
nd
to 6
th
.

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338
Staley’s classification offers a simple model
for groups engaged in protocol-based clinical
research examining innovative multimodality
treatment strategies for patients with
pancreatic cancer [1].
There is no consensus on what constitutes
‘standard’ adjuvant therapy. The high rate of
locoregional failure following surgical
resection for adenocarcinoma of the pancreas
has prompted investigators to evaluate the
role of adjuvant chemo-XRT. The Gastro-
intestinal Tumor Study Group (GITSG) [2]
showed improved survival in the patients
receiving adjuvant chemo-XRT (21 months)
vs. observation (10.9 months) and set up the
platform for future studies. The European
Study Group for Pancreatic Cancer (ESPAC)
assessed the roles of chemo-XRT and
chemotherapy in a randomized study:
ESPAC-1 [3]. The median survival for
patients receiving chemo-XRT was 15.5
months, compared with 16.1 months among
patients who did not receive chemo-XRT
(HR: 1.18, 95% CI: 0.90-1.55; P=0.24). The
median survival for patients receiving
chemotherapy was 19.7 months, compared
with 14.0 months in patients who did not
receive chemotherapy (HR: 0.66; 95% CI:
0.52-0.83; P<0.001). Interpretation of this
study is complicated slightly because 2
different study designs are used: a 2x2
factorial design and direct head-to-head
comparisons (chemotherapy vs. no chemo-
therapy and chemo-XRT vs. no chemo-XRT).
Eligible patients were pre-enrolled in one of
the above strategies. The authors then
reported their findings for each of the separate
study designs as well as for the pooled data.
The question is whether this study should
change our practice with regard to how we
treat patients whose pancreatic cancer was
resected. The answer is no - at least not yet.
XRT, at the very least, serves to decrease the
chances of local recurrence (not examined in
this study), which ultimately may influence
patients' quality of life down the road.
However, a compelling argument can be
made that identification of an effective
systemic regimen to eradicate micro-
metastases and reduce the opportunity for
metastasis may not be the most critical factor
in improving these patients' chances for long-
term survival. This ESPAC-1 study uses only
a 5-FU-based chemotherapy regimen; and
certainly, a gemcitabine-based approach is the
most logical place to start, which was recently
evaluated in combination with chemo-XRT
(using 5-FU as radiosensitizer) in the RTOG
9704 study presented at the annual meeting of
ASCO, 2006. Moreover, CONKO-001 study
compared gemcitabine vs. observation [4].

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For patients with localized disease that is not
amenable to surgical resection, chemotherapy
and radiotherapy or chemotherapy are the
common treatment options. The addition of
chemotherapy to radiation may enhance the
local effects of radiation or provide treatment
of disease outside the radiation field. The
results of clinical trials evaluating the
appropriate therapy for locally advanced or
resected disease have been inconsistent.
Recognizing which patients are likely to
benefit from combination therapy or systemic
therapy alone is a subject of future and
ongoing clinical trials [5].
Gemcitabine, the standard chemotherapy for
pancreatic cancer, offers modest improvement
of tumor-related symptoms (clinical benefit
response) and marginal advantage of survival
[6, 7].
Strategies to improve the efficacy of
gemcitabine include combining with other
cytotoxic agents, biologic agents, or radiation
or administer as a FDR infusion.
On the basis of pharmacokinetic data, studies
have been performed using an FDR of
gemcitabine of 10 mg/m
2
/min in an effort to
maintain a critical plasma concentration of
gemcitabine, and thus increase tumor
cytotoxicity and therapeutic efficacy.

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Gemcitabine is a prodrug that is initially
phosphorylated by deoxycytidine kinase to
gemcitabine monophosphate (dF-dCMP), and
subsequent phosphorylation steps yield
gemcitabine diphosphate (dF-dCDP) and
gemcitabine
triphosphate
(dF-dCTP).
Gemcitabine diphosphate inhibits ribonucleot-
ide reductase, decreasing the cellular pool of
deoxycytidine triphosphate that competes
with gemcitabine triphosphate for
incorporation into DNA. Incorporation of
gemcitabine triphosphate into DNA inhibits
replication with subsequent induction of
apoptosis. Gemcitabine is cleared through
metabolic elimination by cytidine deaminase
and cytidylate deaminase, respectively.
Phosphorylation of gemcitabine to the
monophosphate by deoxycytidine kinase is
the rate-limiting step in the accumulation of
the active diphosphate and triphosphate
metabolites. The activity of gemcitabine is
dependent on its phosphorylation to its
triphosphate, the major intracellular
metabolite. Although doses of gemcitabine
ranging between 800 and 2,800 mg/m2 are
generally administered by intravenous
infusion over 30 minutes, there is evidence
that this generates plasma gemcitabine
concentrations that greatly exceed the levels
(15 to 20 µmol/L) that saturate the rate of
triphosphate accumulation. Alternatively,
gemcitabine infusion at the fixed dose rate of
10 mg/m2/min has been demonstrated to
maximize the rate of triphosphate formation,
and enhance cytotoxicity.
This slide shows the efficacy of the different
schedules of gemcitabine used and GemOx in
advanced pancreatic cancer (randomized trial)
[7, 8, 9].
The studies discussed here include the present
ones [10, 11,12, 13].
Patients post gross total resection of
pancreatic adenocarcinoma were eligible.
Patients were stratified by nodal status
(uninvolved vs. involved), primary tumor
diameter (less than 3 cm vs. equal to or
greater than 3 cm) and surgical margins
(negative vs. positive vs. unknown).

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341
Patients were randomized to receive pre and
post chemo-XRT 5-FU vs. pre and post
chemo-XRT gemcitabine.
No significant difference in non-hematologic
grade equal to or greater than 3 toxicity was
seen. The grade 4 hematologic toxicity rate
was 14% in the gemcitabine arm and 2% in
the 5-FU arm (P<0.001) without difference in
febrile neutropenia.
Patients with pancreatic head tumors (n=381)
experienced significantly improved survival,
with median and 3-year survival of 36.9
months and 32%, respectively, for the
gemcitabine arm (B) vs. 20.6 months and 21%
for the 5-FU arm (A). When analysis was
inclusive of patients with body/tail tumors
(n=442) no significant difference in survival
was found.
The study concluded that the addition of
gemcitabine to postoperative adjuvant 5-FU-
XRT significantly improves survival in
patients with pancreatic head adeno-
carcinoma.
ESPAC-3 (a randomized phase III trial) is
currently enrolling patients with resected
pancreatic cancer to compare among 5-FU +
folinic acid (FA) vs. gemcitabine vs.
observation [14].

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This randomized study evaluated whether initial
Chemo-XRT adds to modern gemcitabine in
term of overall survival [5, 7, 15].
Patients (WHO status 0-2) with confirmed
locally advanced, unresectable but
nonmetastatic pancreatic adenocarcinoma,
were randomized 1:1 between Chemo-XRT
(60 Gy in 6 weeks, 2 Gy/fraction,
concomitant with 5-FU, 300 mg/m
2
/day as a
continuous infusion, day 1-5 every week and
cisplatin, 20 mg/m
2
/day, day 1-5 at week 1
and 5) or gemcitabine (1,000 mg/m
2
weekly
for 7 out of 8 weeks) as induction treatment.
Maintenance treatment consisted of
gemcitabine administered as 1,000 mg/m
2
weekly for 3 out of 4 weeks in both arms until
progression or limiting toxicity.
Increased hematological and gastrointestinal
toxicity was observed in patients receiving
Chemo-XRT.
At median follow-up of 16 months, overall
survival at 6 and 12 months were 78% vs.
82% and 24% vs. 51%, with a median
survival of 8.4 vs. 14.3 months (stratified log-
rank P=0.014) for chemo-XRT vs.
gemcitabine arms, respectively.
The study concluded that gemcitabine alone
allowed a significant overall survival in
locally advanced nonmetastatic pancreatic
cancer. Study was stopped before the planned
inclusion due to lower survival with initial
chemo-XRT when compared to gemcitabine
alone.

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343
Pooled analysis of two randomized trials
(GERCOR/GISCAD:
GemOx
vs.
gemcitabine; German multicenter trial:
gemcitabine plus cisplatin vs. gemcitabine)
was presented at the meeting. Standard
methods for meta-analysis based on
individual patient data were used.
This meta-analysis clearly shows that
progression-free and overall survivals were
significantly superior in the gemcitabine plus
platinum compound patients. In fact, this
group of patients had both hazard rates (HRs)
significantly lower than 1 when compared to
the gemcitabine alone treated group.
Locally advanced and PS 0 patients may
achieve a greater benefit in progression-free,
as well as in overall survival.
This pooled data analysis concluded that
combination of gemcitabine with a platinum
analog such as oxaliplatin or cisplatin
significantly improves progression-free
survival and overall survival as compared to
single-agent gemcitabine in advanced
pancreatic cancer. PS 0 patients may achieve
a greater benefit in progression-free as well as
in overall survival. This is similar to data
reported by Hermann at the 2005 ASCO
Meeting [16] with gemcitabine +
capecitabine.
If we compare the benefit of adding a
platinum compound with capecitabine or
erlotinib from other randomized trials [16,
17], it is evident that a gemcitabine plus
platinum agent has a comparable activity.
It is important to appreciate that the dose
intensity as well as the schedule of
gemcitabine was different among the patients
included in the study. Also, the platinum
agent were different in different studies:
oxaliplatin vs. cisplatin and whether these
agents are cross-resistant in this disease is not
known.

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However, the limitations of a pooled analysis
cannot be ignored. It is important to note that
extent of disease and PS are two important
prognostic factors. It will take a lot of patients
to show a difference in a randomized trial.
ECOG 6201 compares overall survival of
standard gemcitabine 1,000 mg/m
2
/30-min
weekly for 7 out of 8 weeks, and then weekly
for 3 out of 4 weeks (arm A) vs. FDR
gemcitabine 1,500 mg/m
2
/150 min (at a rate
of 10 mg/m
2
/min) weekly for 3 out of 4 weeks
(arm B) or gemcitabine 1,000 mg/m
2
/100-min
day 1 plus oxaliplatin 100 mg/m
2
day 2 every
14 days (arm C).
The primary endpoint of the study is overall
survival and secondary endpoints are the
comparison of the experimental regimens,
toxicity, response, patterns of failure,
progression-free survival and quality-of-life.
Prior adjuvant radiosensitizing 5-FU was
permitted. Patients were stratified by PS 0-1
vs. 2 and locally advanced vs. metastatic
disease.
Fixed dose rate and GemOx with increased
but manageable toxicity:
• higher hematologic toxicity and nausea and
vomiting with fixed dose rate;
• higher neuropathy with GemOx.

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GemOx and FDR gemcitabine have higher
response rate than 30-minute gemcitabine.
Median overall survival for arms A, B, and C
are 4.9, 6.0, and 6.5 months, respectively.
Hazard ratio A vs. B is 1.21 with stratified log
rank P=0.053 and for A vs. C is 1.22 with
stratified log rank P=0.045. Therefore, the
overall survival was significantly improved in
arm C than in 30-min gemcitabine (arm A).
The study concluded that both FDR and
GemOx had approximately 1-month longer
median overall survival than standard
gemcitabine, but not statistically significant.
Three major randomized studies are
evaluating the role of incorporating
bevacizumab and cetuximab with gemcitabine
and irinotecan plus docetaxel in advanced
pancreatic cancer [18, 19, 20].
Based on the results presented at the annual
meeting, it again comes to us that a better
understanding of the biology of pancreatic
cancer is mandatory and evaluation of novel
agents is crucial. Newer imaging techniques
may help to gauge disease better. Palliative
care is an integral part in the management of
patients with pancreatic cancer. We can not
underestimate this as data suggest that

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improved pain control alone impacts on
survival in this disease.
We as oncologist have to change our attitudes
towards clinical trials and need to think
beyond a trial design such as gemcitabine vs.
gemcitabine plus drug A.
Study design such as locally advanced and
metastatic patients need to be studied
separately. Environment within which
research is being conducted also has to be
changed and last, but not the least, access to
trials for patients is the key step in the fight
against pancreatic cancer.
Single agent gemcitabine remains the
standard of care in North America. FDR
gemcitabine is not 30-minute infusion
gemcitabine. However, the toxicity and cost
(time of infusion) associated with FDR
gemcitabine cannot be overlooked. Sadly to
say, but the further evaluating the role of
platinum compounds is not indicated
anymore. FCCD-SFRO is another study
negating benefit of platinum compounds.
However, it is clear that addition of these
compounds to gemcitabine offer higher
response rate and should not be forgotten. We
need to identify surrogates for survival and
accelerate testing new drugs, including
targeted agents. We must consider focusing
on improving adjuvant treatment and second-
line treatment as most first-line regimens
failed in the last decade. It is also important to
standardize our approach towards design,
analysis, and reporting. Finally, we need to
move away from “ONE SIZE FITS ALL”
approach to TAILORED patient management.
Keywords
bevacizumab;
cetuximab;
Cisplatin;
Chemotherapy,
Adjuvant;
gemcitabine; Epidermal Growth Factor;
erlotinib; Fluorouracil; oxaliplatin; Pancreatic
Neoplasms;
Radiation;
Radiotherapy,
Adjuvant; Quinazolines; Vascular Endothelial
Growth Factor A
Abbreviations ASCO: American Society of
Clinical Oncology; CONKO: Charité
Onkologie - clinical studies in GI cancers;
ECOG: Eastern Cooperative Oncology
Group; EGFR: epidermal growth factor
receptor; ESPAC: European Study Group of
Pancreatic Cancer; FA: folinic acid; FDR:
fixed dose rate; FFCD-SFRO: Federation
Francophone de Cancerologie Digestive and

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Societe Francaise de Radiotherapie
Oncologique; Gem: gemcitabine; GemOx:
gemcitabine plus oxaliplatin; GERCOR:
Groupe d'Etude et de Recherche en
Cancreologie Onco-Radiotherapic; GISCAD:
Italian Group for the Study of Gastrointestinal
Tract Carcinomas; GITSG: Gastro-Intestinal
Study Group; HR: hazard ratio; LBA: late
breaking abstract; PS: performance status;
RECIST: Response Evaluation Criteria in
Solid Tumors; RTOG: Radiation Therapy
Oncology Group; XRT: radiation/
radiotherapy
Acknowledgement The author is grateful to
the authors/presenters of the major studies
discussed in this review article:
Chauffert B. Unite INSERM 517, Faculty of
Medicine, 7, Boulevard Jeanne d'Arc, BP
87900,
21079,
Dijon,
France.
bchauffert@dijon.fnclcc.fr (FCCD-SFRO).
Louvet C. Institut National de la Sante et de la
Recherche Medicale (INSERM), Unit 643
and Institut de Transplantation et de
Recherche en Transplantation (ITERT),
Nantes, France. christophe.louvet@sat.ap-
hop-paris.fr (meta-analysis: GERCOR/
GISCAD).
Poplin EA. Cancer Center of New Jersey,
New Brunswick, New Jersey 08901, USA.
poplinea@umdnj.edu (ECOG 6201).
Regine WF. University of Maryland School
of Medicine, Radiation Oncology Clinical,
Gudelsky Tower; Room GGK-17E,
Baltimore,
MD
21201,
USA.
wregine@umm.edu (RTOG 9704).
Correspondence
Muhammad Wasif Saif
Section of Medical Oncology
Yale University School of Medicine
333 Cedar Street; FMP 116
New Haven, CT 06520
USA
Phone: +1-203.737.1569
Fax: +1-203.785.3788
E-mail: wasif.saif@yale.edu
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