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Brief Summary

GUIDELINE TITLE

Second-line or subsequent systemic therapy for recurrent or progressive non-small cell lung cancer: a clinical practice guideline.

BIBLIOGRAPHIC SOURCE(S)

  • Noble J, Ellis P, Mackay JA, Evans WK, Lung Cancer Disease Site Group. Second-line or subsequent systemic therapy for recurrent or progressive non-small cell lung cancer: a clinical practice guideline. Toronto (ON): Cancer Care Ontario (CCO); 2006 Mar 27. 51 p. (Evidence-based series; no. 7-19). [89 references]

GUIDELINE STATUS

** REGULATORY ALERT **

FDA WARNING/REGULATORY ALERT

Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory and/or warning information has been released.

  • September 23, 2008, Tarceva (erlotinib): OSI Pharmaceuticals and Genentech notified healthcare professionals that cases of hepatic failure and hepatorenal syndrome, including fatalities, have been reported during use of Tarceva, particularly in patients with baseline hepatic impairment. New information has been provided in the revised prescribing information, and other recommendations are included in the WARNINGS and DOSAGE AND ADMINISTRATION sections.

BRIEF SUMMARY CONTENT

 ** REGULATORY ALERT **
 RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

 Go to the Complete Summary

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

  • Single-agent docetaxel (Taxotere®) at a dose of 75 mg/m2 every three weeks is recommended as second-line therapy for patients with recurrent or progressive non-small cell lung cancer (NSCLC) and adequate performance status (0-2).
  • Single-agent pemetrexed (Alimta®) at a dose of 500 mg/m2 every three weeks is also an option for second-line therapy of recurrent or progressive disease, if available. This chemotherapy should be administered with vitamin supplements: oral folic acid 350-1,000 micrograms daily and intramuscular vitamin B12 1,000 micrograms every nine weeks, beginning between one to two weeks before, and continuing until three weeks after chemotherapy.
  • Oral topotecan at a dose of 2.3 mg/m2 administered day 1-5 every three weeks is not recommended for second-line therapy of recurrent or progressive disease.
  • Docetaxel administered at a dose of 33.3-40 mg/m2 (for six weeks on an eight-week cycle or for three weeks on a four-week cycle) may be considered in patients at high risk of hematologic toxicity or with a previous history of febrile neutropenia using the three-weekly docetaxel schedule.
  • Combination chemotherapy (docetaxel-based or other) is not currently recommended as second-line or subsequent therapy for recurrent or progressive disease.
  • Erlotinib at a dose of 150 mg/day is recommended as third-line therapy for patients with advanced recurrent or progressive non-small cell lung cancer who maintain a good performance status following previous platinum-based and docetaxel (or pemetrexed) chemotherapy. Erlotinib is also an option for second-line therapy, particularly in patients who are not candidates for chemotherapy or for those with progression after first-line docetaxel-platinum chemotherapy.
  • Gefitinib at a dose of 250 mg/day may be considered for second-line and subsequent therapy only for selected symptomatic patients who are not candidates for chemotherapy and for whom erlotinib is not available.

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The recommendations are supported by randomized phase II and III trials.

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

  • Noble J, Ellis P, Mackay JA, Evans WK, Lung Cancer Disease Site Group. Second-line or subsequent systemic therapy for recurrent or progressive non-small cell lung cancer: a clinical practice guideline. Toronto (ON): Cancer Care Ontario (CCO); 2006 Mar 27. 51 p. (Evidence-based series; no. 7-19). [89 references]

ADAPTATION

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

DATE RELEASED

2001 Jan 17 (revised 2006 Mar 27)

GUIDELINE DEVELOPER(S)

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

GUIDELINE DEVELOPER COMMENT

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.

SOURCE(S) OF FUNDING

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

GUIDELINE COMMITTEE

Provincial Lung Cancer Disease Site Group

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

All members of the Lung Cancer Disease Site Group disclosed potential conflict of interest information. None of the authors of this systematic review declared any conflicts of interest.

GUIDELINE STATUS

GUIDELINE AVAILABILITY

AVAILABILITY OF COMPANION DOCUMENTS

PATIENT RESOURCES

None available

NGC STATUS

This summary was completed by ECRI on July 19, 2002. The information was verified by the guideline developer on August 19, 2002. This summary was updated by ECRI on September 9, 2005. The updated information was verified by the guideline developer on October 3, 2005. This summary was updated by ECRI on June 8, 2006. The updated information was verified by the guideline developer on June 26, 2006. This summary was updated by ECRI Institute on October 16, 2008 following the U.S. Food and Drug Administration (FDA) advisory on Tarceva (erlotinib).

COPYRIGHT STATEMENT

DISCLAIMER

NGC DISCLAIMER

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Readers with questions regarding guideline content are directed to contact the guideline developer.


 

 

   
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