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Alemtuzumab (Antineoplastic) (Monograph)

Drug class: Antineoplastic Agents

Medically reviewed by Drugs.com on May 10, 2024. Written by ASHP.

Warning

    Risk of Cytopenias
  • Risk of serious, sometimes fatal, pancytopenia/marrow hypoplasia, autoimmune idiopathic thrombocytopenia (ITP), and autoimmune hemolytic anemia.1

  • Do not administer single doses >30 mg or cumulative weekly doses >90 mg, since these dosages have been associated with an increased incidence of pancytopenia.1

    Risk of Infections
  • Risk of serious, sometimes fatal, bacterial, viral, fungal, and protozoan infections.1

  • Administer prophylaxis against Pneumocystis jiroveci (formerly P. carinii) pneumonia (PCP) and herpes virus infections.1

    Infusion Reactions
  • Risk of serious, potentially fatal, infusion reactions.1

  • Carefully monitor patients during infusions and withhold therapy for grade 3 or 4 infusion reactions; gradually titrate dosage during initiation of therapy and after interruption of therapy for ≥7 days.1

Introduction

Antineoplastic and immunomodulatory agent; recombinant DNA-derived humanized anti-CD52 monoclonal antibody.1

Uses for Alemtuzumab (Antineoplastic)

Chronic Lymphocytic Leukemia

Used as a single agent for treatment of B-cell chronic lymphocytic leukemia (B-CLL); has been used in both previously untreated and previously treated patients (i.e., patients who have been treated with alkylating agents and who have not responded adequately to fludarabine therapy).1 3 4 6 7 8 10 20 31

As of September 2012, alemtuzumab (Campath) no longer is commercially available in the US, but may be obtained through the Campath Distribution Program for patients who require continued access to the drug.37 Additional information about the Campath Distribution program is available at 877-422-6728.37

Alemtuzumab (Antineoplastic) Dosage and Administration

General

Pretreatment Screening

Patient Monitoring

Premedication and Prophylaxis

Administration

Administer by IV infusion.1 Do not administer by rapid IV injection (e.g., IV push or bolus).1 For treatment of B-CLL,also has been administered by sub-Q injection [off-label].34 35 36

Do not mix with any other drug or administer any other drug simultaneously in the same IV line.1

Vials are for single use only and do not contain a preservative.1

Must be diluted prior to IV infusion.1

Do not shake vial prior to use.1

Use strict aseptic technique.1

Compatible with polyvinylchloride (PVC) bags and PVC or polyethylene-lined PVC administration sets.1

Dilution

Use a 1 mL syringe calibrated in increments of 0.01 mL when preparing a 3-mg dose or a 10-mg dose; for a 30-mg dose, use a 1 or 3 mL syringe calibrated in increments of 0.1 mL.1

To prepare a 3-mg dose, withdraw 0.1 mL of alemtuzumab concentrate from a vial containing 30 mg in 1 mL of drug, and add to 100 mL of 0.9% sodium chloride or 5% dextrose injection.1

To prepare a 10-mg dose, withdraw 0.33 mL of alemtuzumab concentrate from a vial containing 30 mg in 1 mL of drug, and add to 100 mL of 0.9% sodium chloride or 5% dextrose injection.1

To prepare a 30-mg dose, withdraw 1 mL of alemtuzumab concentrate from a vial containing 30 mg in 1 mL of drug, and add to 100 mL of 0.9% sodium chloride or 5% dextrose injection.1

Discard any unused portion after withdrawal of dose.1

Gently invert infusion bag to mix solution.1

Rate of Administration

Administer IV infusion over 2 hours.1

Dosage

Adults

B-CLL
IV

Gradual titration to the recommended maximum single dose of 30 mg administered 3 times weekly on alternate days (e.g., Monday, Wednesday, Friday) is required during initiation of therapy and if therapy is interrupted for ≥7 days.1 In most patients, escalation to the 30 mg dose can be accomplished in 3–7 days.1

Manufacturer's recommended dose escalation strategy is as follows:

Administer 3 mg daily until infusion-related reactions are ≤grade 2, then increase dosage to 10 mg daily.1 Continue at this dosage until infusion-related reactions are ≤grade 2, and then increase to 30 mg 3 times weekly on alternate days (e.g., Monday, Wednesday, Friday).1 Total duration of therapy, including initial dose escalation, is 12 weeks.1

Single doses >30 mg or cumulative weekly doses >90 mg increase the incidence of pancytopenia.1

Sub-Q† [off-label]

In some clinical trials, dose was escalated from an initial dosage of 3 mg daily to a maintenance dosage of 30 mg 3 times weekly.34 35 36 If local skin erythema or edema occurred, dosage escalation phase was prolonged to 1 or 2 weeks.34 36

Some experts recommend that sub-Q therapy be given for at least 12 weeks.36 In a clinical trial in previously untreated patients, the drug was administered up to 18 weeks;34 in another clinical trial in previously treated patients, total duration of therapy was up to 12 weeks.35

Local reactions, including erythema, edema, pruritus, and pain, have been reported, generally during the first 1–2 weeks of therapy, in patients receiving sub-Q [off-label] therapy.34 35 36 Some experts state that if symptomatic local reactions occur during dosage escalation, the escalation period may be prolonged to up to 2 weeks.34 36

Dosage Modification for Toxicity and Contraindications to Continued Therapy
Hematologic Toxicities

Adjust dosage and/or temporarily discontinue therapy if severe cytopenias (except lymphopenia) occur; permanently discontinue drug in patients with evidence of autoimmune hematologic toxicity (i.e., autoimmune anemia or thrombocytopenia). See Table 1 for adjustments for hematologic toxicities.

No dosage modifications recommended for lymphopenia.1

Table 1. Dosage Adjustments for Hematologic Toxicities1

Hematologic Measurements

Comments

For first occurrence of ANC <250/mm3 and/or platelets ≤25,000/mm3

Temporarily discontinue therapy. When ANC ≥500/mm3 and platelets ≥50,000/mm3, resume therapy at maintenance dosage (i.e., 30 mg 3 times weekly).1

If ≥7 days have elapsed since discontinuance of alemtuzumab, reinitiate therapy at 3 mg daily and escalate to 10 mg daily and then to 30 mg 3 times weekly as tolerated.1

For second occurrence of ANC <250/mm3 and/or platelets ≤25,000/mm3

Temporarily discontinue therapy. When ANC ≥500/mm3 and platelets ≥50,000/mm3, resume therapy at 10 mg 3 times weekly; higher dosages not recommended.1 5

If ≥7 days have elapsed since discontinuance of alemtuzumab, reinitiate therapy at 3 mg daily and escalate to 10 mg daily and then to 30 mg 3 times weekly as tolerated.1

For third occurrence of ANC <250/mm3 and/or platelets ≤25,000/mm3

Discontinue alemtuzumab permanently.1

For first occurrence of a decrease of ANC and/or platelets by ≥50% from baseline value in patients initiating therapy with a baseline ANC ≤250/mm3 and/or baseline platelets ≤25,000/mm3

Temporarily discontinue therapy. When ANC and/or platelets return to baseline values, resume therapy at maintenance dosage (i.e., 30 mg 3 times weekly).1 5

If ≥7 days have elapsed since discontinuance of alemtuzumab, reinitiate therapy at 3 mg daily and escalate to 10 mg daily and then to 30 mg 3 times weekly as tolerated.1

For second occurrence of a decrease of ANC and/or platelets by ≥50% from baseline value in patients initiating therapy with ANC of ≤250/mm3 and/or platelets ≤25,000/mm3

Temporarily discontinue therapy. When ANC and/or platelets return to baseline values, resume therapy at 10 mg 3 times weekly.1

If ≥7 days have elapsed since discontinuance of alemtuzumab, reinitiate therapy at 3 mg daily and escalate to 10 mg 3 times weekly as tolerated.1

For third occurrence of a decrease of ANC and/or platelets by ≥50% from baseline value in patients initiating therapy with ANC <250/mm3 and/or platelets ≤25,000/mm3

Discontinue alemtuzumab permanently.1

Infusion Reactions

Withhold therapy in patients experiencing grade 3 or 4 infusion reactions.1

Infectious Complications

If serious infection occurs, temporarily discontinue therapy; may reinitiate therapy following resolution of infection.1

Withhold therapy during antiviral therapy for CMV infection or confirmed CMV viremia (defined as positive for CMV according to PCR in ≥2 consecutive samples obtained ≥1 week apart) and initiate anti-infective therapy (ganciclovir or equivalent).1

Special Populations

Hepatic Impairment

Manufacturer makes no dosage adjustment recommendations.1

Renal Impairment

Manufacturer makes no dosage adjustment recommendations.1

Geriatric Patients

Manufacturer makes no dosage adjustment recommendations.1

Cautions for Alemtuzumab (Antineoplastic)

Contraindications

Warnings/Precautions

Warnings

Cytopenias

Risk of severe (sometimes fatal) cytopenias, including autoimmune anemia, thrombocytopenia, neutropenia, pancytopenia, and prolonged myelosuppression.1 (See Boxed Warning.)

Hemolytic anemia, pure red cell aplasia, bone marrow aplasia, and hypoplasia have occurred in patients receiving recommended dosages for B-CLL.1 Increased incidence of pancytopenia with higher than recommended dosages (i.e., single doses >30 mg or cumulative weekly doses >90 mg).1

Withhold therapy if severe cytopenia (except lymphopenia) occurs.1 Discontinue therapy in patients who develop autoimmune hematologic toxicity (i.e., autoimmune anemia or thrombocytopenia) or recurrent or persistent severe cytopenias (except lymphopenia).1 Safety of reinitiating alemtuzumab in patients with autoimmune cytopenia or bone marrow aplasia not established.1

Infusion-related Reactions

Risk of serious syncope, pulmonary infiltrates, acute respiratory distress syndrome (ARDS), respiratory arrest, cardiac arrhythmias, myocardial infarction, acute cardiac insufficiency, cardiac arrest, angioedema, and anaphylactoid shock.1 (See Boxed Warning.) Other possible manifestations may include rigors, fever, bronchospasm, chills, nausea, vomiting, rash, urticaria, dyspnea, and hypotension.1

In some cases, infusion reactions may occur more frequently during first week of therapy..1

Monitor patients closely for infusion-related reactions during and shortly after infusion; withhold therapy if a grade 3 or 4 infusion reaction occurs. Initiate medical management (e.g., glucocorticoids, epinephrine, meperidine) as clinically indicated.1

Immunosuppression/Infectious Complications

Risk of serious (sometimes fatal) opportunistic bacterial, viral, fungal, or protozoan infections resulting from severe and profound lymphopenia.1 (See Boxed Warning.)

Administer prophylactic anti-infectives against PCP and herpes virus infections during alemtuzumab therapy and for at least 2 months after the last dose is administered or until CD4+ count is ≥200 cells/mm3 (whichever occurs later)1

Monitor patients closely for CMV infection during and for at least 2 months following completion of therapy.1 Withhold therapy for serious infections and during antiviral treatment for CMV infection or confirmed CMV viremia (defined as polymerase chain reaction [PCR] positive CMV in ≥2 consecutive samples obtained 1 week apart).1 Initiate therapeutic ganciclovir (or equivalent) for CMV infection or confirmed CMV viremia.1

Monitor for signs and symptoms of Epstein-Barr virus infection.1

If serious infection occurs, temporarily withhold therapy until infection resolves.1

Severe and prolonged lymphopenia may increase the potential for tranfusion-associated graft versus host disease (TA-GVHD).1 Administer only irradiated blood products unless immediate transfusion is required.1

Other Warnings and Precautions

Immunization

Safety of immunization with live viral vaccines following alemtuzumab therapy not studied.1

Do not administer live viral vaccines to patients or infants born to patients receiving the drug.1

Immunogenicity

Potential for immunogenicity with use of all therapeutic proteins including alemtuzumab.1 Development of antibodies (including neutralizing antibodies) to alemtuzumab reported.1

Specific Populations

Pregnancy

No adequate data in pregnant women; however, may cause fetal harm.1 Embryolethality demonstrated in animal studies.1

Advise women of potential risk to fetus.1

Infants born to pregnant women treated with alemtuzumab may be at increased risk for infections.1

Lactation

Distributed into milk in animals; not known whether distributed into human milk.1 Effects of the drug on nursing infant or on milk production not known.1

Because of the potential for serious adverse reactions, advise lactating women not to breastfeed during treatment and for at least 3 months following the last dose.1

Females and Males of Reproductive Potential

May cause fetal harm.1 Pregnancy testing recommended for females of reproductive potential prior to initiating therapy.1

Advise female patients of reproductive potential to use effective contraception during treatment and for at least 3 months after the last dose.1

May impair fertility in females and males of reproductive potential; reversibility of this effect not known.1

Pediatric Use

Safety and efficacy not established.1

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.1

Hepatic Impairment

Pharmacokinetics not evaluated.1 Safety and efficacy not established.5

Renal Impairment

Pharmacokinetics not evaluated.1 Safety and efficacy not established.5

Common Adverse Effects

Common adverse reactions: infusion reactions (pyrexia, chills, hypotension, urticaria, nausea, rash, tachycardia, dyspnea), cytopenias (neutropenia, lymphopenia, thrombocytopenia, anemia), infections (e.g., CMV viremia, CMV infection, other infections), adverse GI effects (nausea, vomiting, diarrhea, abdominal pain), adverse neurologic effects (insomnia, anxiety).1

Drug Interactions

No formal drug interaction studies to date.1 5

Live Vaccines

Because of the immunosuppressive effects of alemtuzumab, live virus vaccines should not be administered following a course of alemtuzumab therapy.1

Alemtuzumab (Antineoplastic) Pharmacokinetics

Absorption

Bioavailability

After 12 weeks of dosing, a 7-fold increase in mean AUC is observed.1

Distribution

Extent

Not known whether distributes into human milk.1

Crosses the placenta.1

Elimination

Elimination Route

Clearance decreases with repeated administration secondary to decreased receptor-mediated clearance (i.e., loss of CD52 receptors in periphery); AUC increases substantially (7-fold) after 12 weeks of IV dosing in B-CLL patients receiving recommended dosages.1

Half-life

Mean half-life is 11 hours (range: 2–32 hours) following the first 30-mg IV dose; mean half-life is 6 days (range: 1–14 days) following the last 30-mg IV dose.1

Stability

Storage

Parenteral

Injection Concentrate for IV Infusion

2–8°C. Do not freeze; if accidentally frozen, thaw at 2–8°C before administration.1 Protect from direct sunlight.1

Following dilution, may store at 15–30°C or under refrigeration (2–8°C); use within 8 hours.1 Protect from light.1

Actions

Advice to Patients

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care. For further information on the handling of antineoplastic agents, see the ASHP Guidelines on Handling Hazardous Drugs at https://www.ahfsdruginformation.com.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Alemtuzumab (Campath) is available only through the Campath Distribution Program.37

Alemtuzumab

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection concentrate, for IV infusion

30 mg/mL

Campath

Genzyme

AHFS DI Essentials™. © Copyright 2024, Selected Revisions May 10, 2024. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

† Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

Only references cited for selected revisions after 1984 are available electronically.

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3. Food and Drug Administration. Oncologic drugs advisory committee sixty-sixth meeting. Bethesda, MD; December 2000. From FDA web site (http://www.fda.gov/ohrms/dockets/ac/cder00.htm, http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3671t2_a.pdf, http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3671t2_b.pdf, http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3671t2_c.pdf).

4. Keating MJ, Flinn I, Jain V et al. Therapeutic role of alemtuzumab (Campath-1H) in patients who have failed fludarabine: results of a large international study. Blood. 2002; 99:3554-61. http://www.ncbi.nlm.nih.gov/pubmed/11986207?dopt=AbstractPlus

5. Berlex Laboratories, Richmond, CA: Personal communication.

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8. Anon. Drugs of choice for cancer. Treat Guidel Med Lett. 2003; 1:41-52. http://www.ncbi.nlm.nih.gov/pubmed/15529105?dopt=AbstractPlus

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10. Rai KR, Freter CE, Mercier RJ et al. Alemtuzumab in previously treated chronic lymphocytic leukemia patients who also had received fludarabine. J Clin Oncol. 2002; 20:3891-7. http://www.ncbi.nlm.nih.gov/pubmed/12228210?dopt=AbstractPlus

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14. Kennedy GA, Seymour JF, Wolf M et al. Treatment of patients with advanced mycosis fungoides and Sezary syndrome with alemtuzumab. Eur J Haematol. 2003; 71:250-6. http://www.ncbi.nlm.nih.gov/pubmed/12950233?dopt=AbstractPlus

15. Lundin J, Hagberg H, Repp R et al. Phase 2 study of alemtuzumab (anti-CD52 monoclonal antibody) in patients with advanced mycosis fungoides/Sezary syndrome. Blood. 2003; 101:4267-72. http://www.ncbi.nlm.nih.gov/pubmed/12543862?dopt=AbstractPlus

16. Uppenkamp M, Engert A, Diehl V et al. Monoclonal antibody therapy with CAMPATH-1H in patients with relapsed high- and low-grade non-Hodgkin’s lymphomas: a multicenter phase I/II study. Ann Hematol. 2002; 81:26-32. http://www.ncbi.nlm.nih.gov/pubmed/11807632?dopt=AbstractPlus

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18. Lundin J, Osterborg A, Brittinger G et al. CAMPATH-1H monoclonal antibody in therapy for previously treated low-grade non-Hodgkin’s lymphomas: a phase II multicenter study. European Study Group of CAMPATH-1H Treatment in Low-Grade Non-Hodgkin’s Lymphoma. J Clin Oncol. 1998; 16:3257-63. http://www.ncbi.nlm.nih.gov/pubmed/9779699?dopt=AbstractPlus

19. Tang SC, Hewitt K, Reis MD et al. Immunosuppressive toxicity of CAMPATH1H monoclonal antibody in the treatment of patients with recurrent low grade lymphoma. Leuk Lymphoma. 1996; 24:93-101. http://www.ncbi.nlm.nih.gov/pubmed/9049965?dopt=AbstractPlus

20. Osterborg A, Dyer MJ, Bunjes D et al. Phase II multicenter study of human CD52 antibody in previously treated chronic lymphocytic leukemia. European Study Group of CAMPATH-1H Treatment in Chronic Lymphocytic Leukemia. J Clin Oncol. 1997; 15:1567-74. http://www.ncbi.nlm.nih.gov/pubmed/9193354?dopt=AbstractPlus

21. Lundin J, Kennedy B, Dearden C et al. No cardiac toxicity associated with alemtuzumab therapy for mycosis fungoides/Sezary syndrome. Blood. 2005; 105:4148-9. http://www.ncbi.nlm.nih.gov/pubmed/15867423?dopt=AbstractPlus

22. Damaj G, Rubio MT, Audard V et al. Severe cardiac toxicity after monoclonal antibody therapy. Eur J Haematol. 2002; 68:324. http://www.ncbi.nlm.nih.gov/pubmed/12144543?dopt=AbstractPlus

23. Herbert KE, Prince HM, Westerman DA. Pure red-cell aplasia due to parvovirus B19 infection in a patient treated with alemtuzumab. Blood. 2003; 101:1654. http://www.ncbi.nlm.nih.gov/pubmed/12560244?dopt=AbstractPlus

24. Crowley B, Woodcock B. Red cell aplasia due to parvovirus b19 in a patient treated with alemtuzumab. Br J Haematol. 2002; 119:279-80. http://www.ncbi.nlm.nih.gov/pubmed/12358942?dopt=AbstractPlus

25. Pawson R, Dyer MJ, Barge R et al. Treatment of T-cell prolymphocytic leukemia with human CD52 antibody. J Clin Oncol. 1997; 15:2667-72. http://www.ncbi.nlm.nih.gov/pubmed/9215839?dopt=AbstractPlus

26. Dearden CE, Matutes E, Cazin B et al. High remission rate in T-cell prolymphocytic leukemia with CAMPATH-1H. Blood. 2001; 98:1721-6. http://www.ncbi.nlm.nih.gov/pubmed/11535503?dopt=AbstractPlus

27. Keating MJ, Cazin B, Coutre S et al. Campath-1H treatment of T-cell prolymphocytic leukemia in patients for whom at least one prior chemotherapy regimen has failed. J Clin Oncol. 2002; 20:205-13. http://www.ncbi.nlm.nih.gov/pubmed/11773171?dopt=AbstractPlus

28. Dearden CE, Matutes E, Cazin B et al. Very high response rates in previously untreated T-cell prolymphocytic leukaemia patients receiving alemtuzumab (Campath-1H) therapy. Blood. 2003; 102:644a, Abstract 2378.

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31. Hillmen P, Skotnicki AB, Robak T et al. Alemtuzumab compared with chlorambucil as first-line therapy for chronic lymphocytic leukemia. J Clin Oncol. 2007; 25:5616-23. http://www.ncbi.nlm.nih.gov/pubmed/17984186?dopt=AbstractPlus

32. FDA Alert: Alemtuzumab (marketed as Campath). Food and Drug Administration; 2005 Nov 30.

33. Rai KR, Peterson BL, Appelbaum FR et al. Fludarabine compared with chlorambucil as primary therapy for chronic lymphocytic leukemia. N Engl J Med. 2000; 343:1750-7. http://www.ncbi.nlm.nih.gov/pubmed/11114313?dopt=AbstractPlus

34. Lundin J, Kimby E, Björkholm M et al. Phase II trial of subcutaneous anti-CD52 monoclonal antibody alemtuzumab (Campath-1H) as first-line treatment for patients with B-cell chronic lymphocytic leukemia (B-CLL). Blood. 2002; 100:768-73. http://www.ncbi.nlm.nih.gov/pubmed/12130484?dopt=AbstractPlus

35. Stilgenbauer S, Zenz T, Winkler D et al. Subcutaneous alemtuzumab in fludarabine-refractory chronic lymphocytic leukemia: clinical results and prognostic marker analyses from the CLL2H study of the German Chronic Lymphocytic Leukemia Study Group. J Clin Oncol. 2009; 27:3994-4001. http://www.ncbi.nlm.nih.gov/pubmed/19597025?dopt=AbstractPlus

36. Osterborg A, Foà R, Bezares RF et al. Management guidelines for the use of alemtuzumab in chronic lymphocytic leukemia. Leukemia. 2009; 23:1980-8. http://www.ncbi.nlm.nih.gov/pubmed/19626051?dopt=AbstractPlus

37. Genzyme Corporation. US Campath Distribution Program. From product web site. Accessed 2015 July 28. http://www.campath.com/

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39. Genzyme Corporation. Lemtrada (alemtuzumab) injection for intravenous use prescribing information. Cambridge, MA; 2014 Nov.

40. Elter T, Gercheva-Kyuchukova L, Pylylpenko H et al. Fludarabine plus alemtuzumab versus fludarabine alone in patients with previously treated chronic lymphocytic leukaemia: a randomised phase 3 trial. Lancet Oncol. 2011; 12:1204-13. http://www.ncbi.nlm.nih.gov/pubmed/21992852?dopt=AbstractPlus

Frequently asked questions