• Malthaner RA, Rumble RB, Program in Evidence-based Care. The role of porfimer sodium (photofrin) in the palliative treatment of esophageal cancer. Toronto (ON): Cancer Care Ontario (CCO); 2006 Jan 11. 10 p. (DQTC-SOS advice report; no. 3). [8 references]

Esophageal cancer

Assessment of Therapeutic Effectiveness
Treatment

Oncology

Physicians

To evaluate the role of porfimer sodium in the palliative treatment of esophageal cancer

Adult patients with esophageal cancer for whom palliative treatment is the therapy of choice

Photodynamic therapy with porfimer sodium

• Relief from symptoms, including dysphagia and pain
• Quality of life scores

Searches of Electronic Databases

Three reports (two randomized controlled trials and one phase II trial) were obtained

Expert Consensus (Committee)

Not applicable

Systematic Review with Evidence Tables

As only two randomized controlled trials (RCTs) were obtained, no pooling of outcome data was performed.

Expert Consensus

This advice report was commissioned by the Program in Evidence-based Care. A member of the Gastrointestinal Cancer Disease Site Group (DSG) agreed to serve as the clinical lead on this topic as it was not formally part of the Gastrointestinal Cancer DSG's portfolio. This advice report is a convenient and up-to-date source of the best available evidence on the role of porfimer sodium in the palliative treatment of esophageal cancer, developed through a systematic review of the available evidence.

The evidence reviewed did not detect a statistically significant difference between photodynamic therapy with porfimer sodium compared with neodymium:yttrium-aluminum-garnet (Nd:YAG) laser for dysphagia palliation (p>0.05). There may be a benefit for patients given porfimer sodium in dietary status at one month as was found in one of the trials, but further trials are need to confirm this observation. This same trial also found a quality of life benefit for porfimer sodium compared with Nd:YAG laser, and treatment with Nd:YAG laser was associated with a drop from baseline quality of life scores.

While randomized trials are available comparing photodynamic therapy using porfimer sodium to Nd:YAG laser, many experts do not feel that Nd:YAG is the appropriate comparator anymore, and are instead advocating best supportive care and the insertion of flexible metal stents to palliate the effects of dysphagia and restore esophageal patency. Following insertion of a current generation flexible metal stent, most patients experience rapid improvement of dysphagia with median scores improving from grade 3 (able to drink liquids only) to a median of grade 1 (able to eat most solid foods). While these stents are effective for palliating the effects of obstructive esophageal cancer, they also have some disadvantages including pain, severe gastrointestinal reflux, stent migration, and the possibility of tumour in-growth into the stent itself. As detailed in the original guideline document, therapy with porfimer sodium also carries some risks, some of which are potentially life-threatening (e.g., esophageal perforation). Unfortunately, no published randomized trials are available comparing photodynamic therapy with porfimer sodium to the latest generation of flexible metal stents.

In consideration of the lack of comparative evidence on what the authors believe to be the existing standard of care (best supportive care and the insertion of flexible metal stents) with photodynamic therapy using porfimer sodium, the guideline developers recommend the following: for patients with contraindications to the insertion of flexible stents, photodynamic therapy with porfimer sodium is a palliative therapy option if the goal of treatment is relief from dysphagia; however, the authors acknowledge that this recommendation is based on expert opinion, and is not based on evidence from a randomized comparison between photodynamic therapy with porfimer sodium and flexible metal stents.

Not applicable

A formal cost analysis was not performed and published cost analyses were not reviewed.

Internal Peer Review

Not stated

See Appendix 2 in the original guideline document for the regimens and dosages used in the included trials.

• The current standard of care for patients undergoing palliative therapy for esophageal cancer is best supportive care including the use of flexible metal stents inserted to restore esophageal patency.
• For patients with contraindications to the insertion of flexible stents, photodynamic therapy with porfimer sodium is a palliative therapy option if the goal of treatment is relief from dysphagia; however, this recommendation is based on expert opinion, and is not based on evidence from a randomized comparison between photodynamic therapy with porfimer sodium and flexible metal stents.

None provided

The recommendations are supported by randomized controlled trials and one Phase II trial.

Currently, the only randomized comparisons available on the use of photodynamic therapy using porfimer sodium are with laser therapy, and laser therapy is rapidly falling out of favour with many clinicians because it is cumbersome, of questionable efficacy, and in many cases, it requires multiple treatments. Evidence reviewed in this report did not detect a statistically significant difference between photodynamic therapy with porfimer sodium compared with neodymium:yttrium-aluminum-garnet (Nd:YAG) laser for dysphagia palliation. While there may be a benefit for patients given porfimer sodium in dietary status at one month as was found in one of the trials, further trials are need to confirm this observation. This same trial also found a quality of life benefit for porfimer sodium compared with Nd:YAG laser, and treatment with Nd:YAG laser was associated with a drop from baseline quality of life scores.

Both of the randomized controlled trials (RCTs) provided data on adverse effects. The Phase II trial reported no adverse event rates. In the randomized controlled trials, photodynamic therapy was associated with the following adverse effects: skin photoreactions, fistula, fever, luminal plugging, nausea, pleural effusion, and esophageal perforation. Table 2 in the original guideline document details the adverse effects observed in the two randomized controlled trials. No grades were given for any of the reported adverse effects.

Care has been taken in the preparation of the information contained in this document. Nonetheless, any person seeking to apply or consult the evidence-based series is expected to use independent medical judgment in the context of individual clinical circumstances or seek out the supervision of a qualified clinician. Cancer Care Ontario makes no representation or guarantees of any kind whatsoever regarding their content or use or application and disclaims any for their application or use in any way.

An implementation strategy was not provided.

End of Life Care

Effectiveness

• Malthaner RA, Rumble RB, Program in Evidence-based Care. The role of porfimer sodium (photofrin) in the palliative treatment of esophageal cancer. Toronto (ON): Cancer Care Ontario (CCO); 2006 Jan 11. 10 p. (DQTC-SOS advice report; no. 3). [8 references]

Not applicable: The guideline was not adapted from another source.

2006 Jan 11

Program in Evidence-based Care - State/Local Government Agency [Non-U.S.]

The Program in Evidence-based Care (PEBC) is a Province of Ontario initiative sponsored by Cancer Care Ontario and the Ontario Ministry of Health and Long-Term Care.

Cancer Care Ontario
Ontario Ministry of Health and Long-Term Care

Cancer Care Ontario's Program in Evidence-based Care

Primary Authors: R.A. Malthaner; R.B. Rumble

Neither of the authors declared any conflicts of interest.

None available

This NGC summary was completed by ECRI on October 27, 2006. The information was verified by the guideline developer on November 24, 2006.