Reviewer's report
Title:Vesicocutaneous fistula formation during treatment with sunitinib malate:
Case report
Version: 2Date:3 September 2010
Reviewer: Georgios Papaetis
Reviewer's report:
Major Compulsory Revisions
1. This case report describes a patient with metastatic GIST treated with imatinib,
who developed an intestinocutaneous fistula after the progression of the disease.
The use of sunitinib as a second line therapy was suggested to promote the
development of a vesicocutaneous communication in the same lession. The
authors should comment about the absence of an infection in the fistula during
the hole course of imatinib and sunitinib treatment more thoroughly (cultures of
fetid discharge, possible use of antibiotics during hospitalization and in the
outpatient setting, inflammatory markers).
2. The authors discuss the potent anti-angiogenic effects of sunitinib, which could
contribute to the formation of the fistula, after response to this drug. Was a
magnetic resonance imaging (MRI) radiography or a dynamic contrast-enhanced
(DCE)-MRI technique performed? DCE-MRI techniques can primarily detect any
vascular alteration achieved when an antiangiogenic agent is been administered
(Padhani AR. Dynamic contrast-enhanced MRI in clinical oncology: current
status and future directions. J Magn Reson Imaging 2002; 16: 407–22). If not, a
comment should be made.
3. Were biopsies performed from the tumor during the response, which could
reveal possible histological findings of TKIs activity (such as tumor necrosis,
myxoid degeneration, vascular changes)? If not, a comment about this should be
made.
4. Was the tumor genotype investigated? Sunitinib was found to be effective for
all pre-imatinib GIST genotypes, but mainly those with a wild-type genotype, a
primary KIT exon 9 mutation or secondary exon 13 or 14 KIT mutations
[Heinrichm, M.C., Maki, R., Corless, C.L. (2006). Sunitinib (SU) response in
imatinib-resistant (IM-R) GIST correlates with KIT and PDGFR mutation status.
Presented at the 42nd annual meeting of the American Society for Clinical
Oncology, Atlanta, GA: 2-6 June]. If not, a comment should be made.
Minor Essential Revisions
1. Background, first paragraph: A comment about the activity of sunitinib in
imatinib-resistant or imatinib-intolerant patients with locally advanced or
metastatic GIST should be made according to reference 6 of the manuscript.
Objective response rates in the sunitinib arm and in the placebo arm were 6.8%
and 0% respectively (p=0.006).
2. Case presentation, paragraph 2: Cultures of the fetid discharge of the
cutaneous fistulae are missing. Was the patient treated with antibiotics at this
stage? If yes, which antibiotics and for how long?
3. Case presentation, paragraph 3: Did the patient had any clinical signs of
infection? What was the CRP- value at that time?
4. The conclusion should summarize better the entire case report.
5. The use of English is often problematic. There are several mistakes in terms of
grammar and syntax.
Discretionary Revisions
1. A comment could be made about the possible correlation of sunitinib-induced
thyroid dysfunction observed and the response to its administration [Wolter P,
Stefan C, Decallonne B, et al. Evaluation of thyroid dysfunction as a candidate
surrogate marker for efficacy of sunitinib in patients (pts) with advanced renal cell
cancer. J Clin Oncol 2008; 26; Abstract: 5126].
2. A short comment could be made about imatinib resistance in GISTs (early and
mainly late progression).
Level of interest: An article of limited interest
Quality of written English: Needs some language corrections before being
published
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
I declare that I have no competing interests
Reviewer's report
Title:Vesicocutaneous fistula formation during treatment with sunitinib malate:
Case report
Version: 2Date:3 September 2010
Reviewer: Georgios Papaetis
Reviewer's report:
Major Compulsory Revisions
1. This case report describes a patient with metastatic GIST treated with imatinib,
who developed an intestinocutaneous fistula after the progression of the disease.
The use of sunitinib as a second line therapy was suggested to promote the
development of a vesicocutaneous communication in the same lession. The
authors should comment about the absence of an infection in the fistula during
the hole course of imatinib and sunitinib treatment more thoroughly (cultures of
fetid discharge, possible use of antibiotics during hospitalization and in the
outpatient setting, inflammatory markers).
2. The authors discuss the potent anti-angiogenic effects of sunitinib, which could
contribute to the formation of the fistula, after response to this drug. Was a
magnetic resonance imaging (MRI) radiography or a dynamic contrast-enhanced
(DCE)-MRI technique performed? DCE-MRI techniques can primarily detect any
vascular alteration achieved when an antiangiogenic agent is been administered
(Padhani AR. Dynamic contrast-enhanced MRI in clinical oncology: current
status and future directions. J Magn Reson Imaging 2002; 16: 407–22). If not, a
comment should be made.
3. Were biopsies performed from the tumor during the response, which could
reveal possible histological findings of TKIs activity (such as tumor necrosis,
myxoid degeneration, vascular changes)? If not, a comment about this should be
made.
4. Was the tumor genotype investigated? Sunitinib was found to be effective for
all pre-imatinib GIST genotypes, but mainly those with a wild-type genotype, a
primary KIT exon 9 mutation or secondary exon 13 or 14 KIT mutations
[Heinrichm, M.C., Maki, R., Corless, C.L. (2006). Sunitinib (SU) response in
imatinib-resistant (IM-R) GIST correlates with KIT and PDGFR mutation status.
Presented at the 42nd annual meeting of the American Society for Clinical
Oncology, Atlanta, GA: 2-6 June]. If not, a comment should be made.
Minor Essential Revisions
1. Background, first paragraph: A comment about the activity of sunitinib in
imatinib-resistant or imatinib-intolerant patients with locally advanced or
metastatic GIST should be made according to reference 6 of the manuscript.
Objective response rates in the sunitinib arm and in the placebo arm were 6.8%
and 0% respectively (p=0.006).
2. Case presentation, paragraph 2: Cultures of the fetid discharge of the
cutaneous fistulae are missing. Was the patient treated with antibiotics at this
stage? If yes, which antibiotics and for how long?
3. Case presentation, paragraph 3: Did the patient had any clinical signs of
infection? What was the CRP- value at that time?
4. The conclusion should summarize better the entire case report.
5. The use of English is often problematic. There are several mistakes in terms of
grammar and syntax.
Discretionary Revisions
1. A comment could be made about the possible correlation of sunitinib-induced
thyroid dysfunction observed and the response to its administration [Wolter P,
Stefan C, Decallonne B, et al. Evaluation of thyroid dysfunction as a candidate
surrogate marker for efficacy of sunitinib in patients (pts) with advanced renal cell
cancer. J Clin Oncol 2008; 26; Abstract: 5126].
2. A short comment could be made about imatinib resistance in GISTs (early and
mainly late progression).
Level of interest: An article of limited interest
Quality of written English: Needs some language corrections before being
published
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
I declare that I have no competing interests
Please review this paper.
user
Reviewer's report
Title:Vesicocutaneous fistula formation during treatment with sunitinib malate:
Case report
Version: 2Date:3 September 2010
Reviewer: Georgios Papaetis
Reviewer's report:
Major Compulsory Revisions
1. This case report describes a patient with metastatic GIST treated with imatinib,
who developed an intestinocutaneous fistula after the progression of the disease.
The use of sunitinib as a second line therapy was suggested to promote the
development of a vesicocutaneous communication in the same lession. The
authors should comment about the absence of an infection in the fistula during
the hole course of imatinib and sunitinib treatment more thoroughly (cultures of
fetid discharge, possible use of antibiotics during hospitalization and in the
outpatient setting, inflammatory markers).
2. The authors discuss the potent anti-angiogenic effects of sunitinib, which could
contribute to the formation of the fistula, after response to this drug. Was a
magnetic resonance imaging (MRI) radiography or a dynamic contrast-enhanced
(DCE)-MRI technique performed? DCE-MRI techniques can primarily detect any
vascular alteration achieved when an antiangiogenic agent is been administered
(Padhani AR. Dynamic contrast-enhanced MRI in clinical oncology: current
status and future directions. J Magn Reson Imaging 2002; 16: 407–22). If not, a
comment should be made.
3. Were biopsies performed from the tumor during the response, which could
reveal possible histological findings of TKIs activity (such as tumor necrosis,
myxoid degeneration, vascular changes)? If not, a comment about this should be
made.
4. Was the tumor genotype investigated? Sunitinib was found to be effective for
all pre-imatinib GIST genotypes, but mainly those with a wild-type genotype, a
primary KIT exon 9 mutation or secondary exon 13 or 14 KIT mutations
[Heinrichm, M.C., Maki, R., Corless, C.L. (2006). Sunitinib (SU) response in
imatinib-resistant (IM-R) GIST correlates with KIT and PDGFR mutation status.
Presented at the 42nd annual meeting of the American Society for Clinical
Oncology, Atlanta, GA: 2-6 June]. If not, a comment should be made.
Minor Essential Revisions
1. Background, first paragraph: A comment about the activity of sunitinib in
imatinib-resistant or imatinib-intolerant patients with locally advanced or
metastatic GIST should be made according to reference 6 of the manuscript.
Objective response rates in the sunitinib arm and in the placebo arm were 6.8%
and 0% respectively (p=0.006).
2. Case presentation, paragraph 2: Cultures of the fetid discharge of the
cutaneous fistulae are missing. Was the patient treated with antibiotics at this
stage? If yes, which antibiotics and for how long?
3. Case presentation, paragraph 3: Did the patient had any clinical signs of
infection? What was the CRP- value at that time?
4. The conclusion should summarize better the entire case report.
5. The use of English is often problematic. There are several mistakes in terms of
grammar and syntax.
Discretionary Revisions
1. A comment could be made about the possible correlation of sunitinib-induced
thyroid dysfunction observed and the response to its administration [Wolter P,
Stefan C, Decallonne B, et al. Evaluation of thyroid dysfunction as a candidate
surrogate marker for efficacy of sunitinib in patients (pts) with advanced renal cell
cancer. J Clin Oncol 2008; 26; Abstract: 5126].
2. A short comment could be made about imatinib resistance in GISTs (early and
mainly late progression).
Level of interest: An article of limited interest
Quality of written English: Needs some language corrections before being
published
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
I declare that I have no competing interests
assistant