Reviewer's report
Title:Vesicocutaneous fistula formation during treatment with sunitinib malate:
Case report
Version: 2Date:3 September 2010
Reviewer: Cristina Gravalos
Reviewer's report:
Cases of fistula formation, sometimes associated with tumor necrosis and/or
regression, in some cases with fatal outcome, have been reported with sunitinib.
However, so far, there are few reports in the literature of patients treated with
sunitinib who developed fistula and more information about this rare adverse
event is needed.
This manuscript describes the case of a woman with advanced GIST treated with
sunitinib after progression to imatinib. She developed a first fistula
(enterocutaneous fistula) after the administration of imatinib and a second fistula
(vesicocutaneous fistula) with sunitinib. This is the first case reported with
vesicocutaneous fistula related with sunitinib. Even more, this case is very
interesting because of the double formation of fistula in a patient with GIST
treated with two different TKIs.
The CT images show that the second fistula was developed in the tumour mass
which infiltrated the abdominal wall and bladder. In this case, sunitinib could
contribute to the development of the tumour fistula associated with tumor
necrosis and it is clear that fistula healed after sunitinib discontinuation.
My comments are:
1. Background
First paragraph. In the phase III trial of sunitinib in GIST, diarrhea is 29% instead
of 33% (see table 2 of the article by Demetri et al. Lancet 2006). Please, modify.
2. Discussion
First paragraph. In the NCIC CTG trial IND 184, four patients had fistulae
develop on study treatment and an additional patient developed a fistula 3.5
months after discontinuation of therapy. No objective responses were observed
in the 19 patients enrolled in the study, even if the absence of fistula. So, please,
modify this sentence: “Those who developed fistulae during treatment in that
study did not develop objective responses, …” because there were no responses
at all.
First paragraph. Ng et al (Gastric Cancer 2003) described the case of one
patient, not patients. So, please modify this sentence: “On the other hand,
notable tumour shrinkage results in the complete healing of fistulae in patients
with GIST under imatinib therapy [10]”.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Acceptable
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: Cristina Gravalos
Reviewer's report:
Cases of fistula formation, sometimes associated with tumor necrosis and/or
regression, in some cases with fatal outcome, have been reported with sunitinib.
However, so far, there are few reports in the literature of patients treated with
sunitinib who developed fistula and more information about this rare adverse
event is needed.
This manuscript describes the case of a woman with advanced GIST treated with
sunitinib after progression to imatinib. She developed a first fistula
(enterocutaneous fistula) after the administration of imatinib and a second fistula
(vesicocutaneous fistula) with sunitinib. This is the first case reported with
vesicocutaneous fistula related with sunitinib. Even more, this case is very
interesting because of the double formation of fistula in a patient with GIST
treated with two different TKIs.
The CT images show that the second fistula was developed in the tumour mass
which infiltrated the abdominal wall and bladder. In this case, sunitinib could
contribute to the development of the tumour fistula associated with tumor
necrosis and it is clear that fistula healed after sunitinib discontinuation.
My comments are:
1. Background
First paragraph. In the phase III trial of sunitinib in GIST, diarrhea is 29% instead
of 33% (see table 2 of the article by Demetri et al. Lancet 2006). Please, modify.
2. Discussion
First paragraph. In the NCIC CTG trial IND 184, four patients had fistulae
develop on study treatment and an additional patient developed a fistula 3.5
months after discontinuation of therapy. No objective responses were observed
in the 19 patients enrolled in the study, even if the absence of fistula. So, please,
modify this sentence: “Those who developed fistulae during treatment in that
study did not develop objective responses, …” because there were no responses
at all.
First paragraph. Ng et al (Gastric Cancer 2003) described the case of one
patient, not patients. So, please modify this sentence: “On the other hand,
notable tumour shrinkage results in the complete healing of fistulae in patients
with GIST under imatinib therapy [10]”.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Acceptable
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: Cristina Gravalos
Reviewer's report:
Cases of fistula formation, sometimes associated with tumor necrosis and/or
regression, in some cases with fatal outcome, have been reported with sunitinib.
However, so far, there are few reports in the literature of patients treated with
sunitinib who developed fistula and more information about this rare adverse
event is needed.
This manuscript describes the case of a woman with advanced GIST treated with
sunitinib after progression to imatinib. She developed a first fistula
(enterocutaneous fistula) after the administration of imatinib and a second fistula
(vesicocutaneous fistula) with sunitinib. This is the first case reported with
vesicocutaneous fistula related with sunitinib. Even more, this case is very
interesting because of the double formation of fistula in a patient with GIST
treated with two different TKIs.
The CT images show that the second fistula was developed in the tumour mass
which infiltrated the abdominal wall and bladder. In this case, sunitinib could
contribute to the development of the tumour fistula associated with tumor
necrosis and it is clear that fistula healed after sunitinib discontinuation.
My comments are:
1. Background
First paragraph. In the phase III trial of sunitinib in GIST, diarrhea is 29% instead
of 33% (see table 2 of the article by Demetri et al. Lancet 2006). Please, modify.
2. Discussion
First paragraph. In the NCIC CTG trial IND 184, four patients had fistulae
develop on study treatment and an additional patient developed a fistula 3.5
months after discontinuation of therapy. No objective responses were observed
in the 19 patients enrolled in the study, even if the absence of fistula. So, please,
modify this sentence: “Those who developed fistulae during treatment in that
study did not develop objective responses, …” because there were no responses
at all.
First paragraph. Ng et al (Gastric Cancer 2003) described the case of one
patient, not patients. So, please modify this sentence: “On the other hand,
notable tumour shrinkage results in the complete healing of fistulae in patients
with GIST under imatinib therapy [10]”.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Acceptable
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