EHP 2006 can we bury

Can We Bury The Idea That Psychotherapy Increases The Survival Of Cancer Patients?James C. Coyne, Ph.D., Michael Stefanek, Ph.D., Steven C. Palmer, Ph.D. jcoyne@ mail.med.upenn.edu

A significant proportion ofbreast cancer patientsattending support groupsdo so with the belief thatthey may be extendingtheir lives (Miller et al.,1998).

Can We Move Beyond the Impasse?Claimed that 5 of 11 randomized trials demonstratean effect of psychosocial intervention on survivaltime.Evidence for a benefit to survival attributable topsychotherapy is, at best, “mixed”, (Lillquist &Abramson, 2002, p. 65), “controversial” (Schattner,2003, p. 618) and “contradictory” (Greer, 2002, p.238).“A definite conclusion about whether psychosocialinterventions prolong cancer survival seemspremature” (Smedslund & Ringdal, 2004, p 123).

It is with a heavy heart that I have concluded that Dr. Coynesuffers from an incurable illness: narcissistic myopia. He is adepression researcher, so successful treatment of mereanxiety symptoms appears meaningless to his limited vision. It… seems to permit him to dismiss the results of 25 years of myand many other colleagues research demonstrating positiveeffects of group support for cancer patients. I can live with hisdistortion of the published data…But when he insults mycolleague Dr. Catherine Classen by referring to her as "Cathy,"and worse insults my patients by informing us that oursupportive/expressive groups are a "waste of seriously illpatients potentially short remaining lives," my tolerance forhis obvious impairment vanishes. One of my patients whoattended our supportive/expressive group for six years said:"This group is the least superficial thing I do in my life." Sheand her family thanked me for it when I visited her homeshortly before she died. David Spiegel, M.D., Stanford University

Re-Evaluating the“Positive Studies”…

Three of the “positive trials” can beeliminated because in each case,patients in the intervention gotsubstantially better medical surveillanceand care.Two of the investigator groups for thesetrials deny that they were even studyingpsychotherapy!

McCorkle R, Strumpf NE, NuamahIF, Adler DC, Cooley ME, Jepson C,Lusk EJ, Torosian M (2000): Aspecialized home care interventionimproves survival among olderpost-surgical cancer patients. JAm Geriatr Soc, 48: 1707-1713

McCorkle et al (2000)Authors distinguish their interventionfrom studies examining psychosocialvariables, stating, “…this is the first[study] to examine the impact of…nursing interventions on survival incancer patients. Other studies havefocused have focused on…patient’spsychosocial status, includingdepressive symptoms, function, and theeffects of support groups” (pp. 1708).

McCorkle et al (2000)“We did what we did really because ofthe physical care. The deaths wererelated to major complications, sepsis,pulmonary embolus, etc. The nursespicked these things up and preventedthe crisis” (McCorkle, personal emailcommunication, August 3, 2004).

Kuchler T, Henne-Burns D,Rappat S, Holst K, Williams JI,Wood-Dauphinee (1999):Impact of psychotherapeuticsupport on gastrointestinalcancer patients undergoingsurgery: Survival results of atrial. Hepato-Gastroenrerol46:322-335

Kuchler et al (1999)Although the length of hospital stay wasapproximately the same in the twogroups, the intervention group receivedalmost twice as much intensive care.Post-treatment, patients in theintervention group reported twice as muchchemotherapy and three times as much“alternative treatment.”

Richardson JL, Shelton DR,Krailo M, Levine AM (1990):The effect of compliancewith treatment on survivalamong patients withhematologic malignancies. JClin Oncol, 8: 356-364.

Richardson et alI would agree that our study was notpsychotherapy. Our study was verybehavioral in concept and delivery -teaching people how to manage the disease,the treatment and the health care system. Ithink you can go a long way with basicpatient education, family education, andhealth care system manipulation strategies. Richardson (Personal communication, Jan 3, 2005)

Spiegel D, Bloom JR, KraemerHC, Gottheil E (1989): Effect oftreatment on the survival ofpatients with metastasic breastcancer. Lancet 2:888-891. Cited 900 Times

Something Odd Occurred in the Control Group.Of the 12 patients assigned to the control group who were still alive at 2 years,all died by one day after the four year anniversary of randomization.inconsistent with typical survival curves for people with cancer, which aregenerally skewed due to a few people surviving markedly longer than the rest.Patients were on average already two years past diagnosis at randomization,so this increased rate of death occurred relatively late.32% of locale-matched women with metastatic breast cancer would beexpected to be alive between 5 and 10 years after diagnosis.Spiegel et al.’s control patients experienced a four-year survival rate of only2.8%.In contrast, the four-year survival of patients randomized to intervention was24%, substantially closer to expected value in the absence of an effectiveintervention and suggesting bias in the initial sampling.

There is a lack of significantdifferences when appropriate statistics are used.Spiegel et al. (1989) report that “the interventiongroup lived on average twice as long as didcontrols” (p. 889).Given the skewness of most survival curves, mediansurvival time is generally considered the betterexpression of central tendency because the medianreduces the possible excessive influence of outliers.Median survival times for Spiegel et al.’s (1989)intervention and control groups were notsignificantly different.

Fawzy, F.I., Canada, A.L., & Fawzy, N.W.(2003). Malignant melanoma: effects of a brief,structured psychiatric intervention on survivaland recurrence at 10-year follow-up. Arch GenPsychiat 60, 100-103.*Fawzy FI, Fawzy NW, Hyun CS, Elashoff R,Guthrie, D, Fahey JL, M orton DL (1993):Malignant melanoma. Effects of an earlystructured psychiatric intervention, coping, andaffective state on recurrence and survival 6years later. Arch Gen Psychiat, 50: 681-689. *Cited Almost 500 Times

Fawzy et al. (1993) and Fawzy et al. (2003)Fawzy et al. (2003) provided a provocative andseemingly compelling summary of the results forthe intervention prolonging survival as assessed atsix and ten year follow up: When controlling for other risk factors, at 5- to 6-year follow-up, participation in the intervention lowered the risk of recurrence by more than 2 1/2 fold (RR = 2.66), and decreased the risk of death approximately 7-fold (RR = 6.89). At the 10-year follow- up, a decrease in risk of recurrence was no longer significant, and the risk of death was 3-fold lower (RR = 2.87) for those who participated in the intervention.

Inappropriate Analysis and Interpretation of Statistics• Fawzy calculated an odds ratio, not a relative risk, and it is an inappropriate statistic for evaluating a clinical trial.• Only 20 deaths in the entire retained sample at 5-6 years, but Fawzy had 6 control variables in his regression analysis, far below any recommended minimum ratio of ten to fifteen events per covariate The risk of spurious findings is high.

Fawzy et al. (1993) and Fawzy et al. (2003)• Despite the dramatic way in which results for 10 year follow up were presented, a log rank test revealed no significant difference between the intervention and control group in overall survival (Fawzy et al, 2003).• Small magnitude of difference between intervention and control group is highlighted by noting that survival differences would become non-significant with the reclassification of a single patient (Fox, 1995; Palmer & Coyne, 2004).

Fawzy et al. (1993) and Fawzy et al. (2003): A Critical Look• Of 40 intervention patients, one was excluded after randomization due to death during the intervention, one due to incomplete baseline data, and a third due to the presence of M ajor Depressive Disorder.• Of the 40 participants randomized to the control condition, only 28 produced complete baseline and 6-month data. Although lack of complete data was a reason for excluding one subject from the intervention condition, survival data were included as much as possible for those in the control condition, regardless of the completeness of their data.

Neither the Spiegel nor the Fawzystudy were designed to test theeffects of psychotherapy onsurvival.Since then, there have been threetrials designed with this goal, andnone of them has yielded a positiveeffect.

Cunningham, A. J., Edmonds, C. V. I., Jenkins, G. P., Pollack, H.,Lockwood, G. A., & Warr, D.,(1998). A randomized controlled trialof the effects of group psychological therapy on survival inwomen with metastatic breast cancer. Psycho-Oncology, 7, 508-517.Goodwin, P. J., Leszcz, M., Ennis, M., Koopmans, J., Vincent, L.,Guther, H., et al. (2001). The effect of group psychosocial supporton survival in metastatic breast cancer. New England Journal ofMedicine, 345, 1719-1726.Kissane, D. W., Love A., Hatton, A., Smith, G., Clarke, D. M., Miach,P., et al. (2004). Effect of cognitive-existential group therapy onsurvival in early-stage breast cancer Journal of Clinical Oncology,22, 4255-4260.

No study that was designed to testwhether psychotherapy improvedsurvival and in which the interventiongroup did not get better medical care hasdemonstrated an effect.Claim that psychotherapy promotessurvival depend on the Spiegel andFawzy studies, which have seriouslimitations.

Should We Attempt More Studies With Metastatic Breast Cancer Patients?We have no credible evidence that psychotherapy promotessurvival, and no compelling evidence for a mechanism thatmight allow an effect.There is evidence for some mechanisms by which biomedicalinterventions might work, but not much success in producingnew, effective biomedical interventions.“Despite more than 3 decades of research, metastatic breastcancer (MBC) remains essentially incurable and, afterdocumentation of metastasis, the median survival time isapproximately 2 years” (Bernard-Marty, Fatima Cardoso, &Piccart, 2004, p.617).

Should We Attempt More Studies With Early Breast Cancer Patients?In the U.S the 5-year survival rate for women with localizedbreast cancer is now 98% (American Cancer Society, 2006).This high rate of survival makes it difficult to demonstrate thatany additional treatment would yield a clinically significantimprovement.An integration of 28 trials of with 16,513 women of whom 3782had died concluded that both tamoxifen and cytotoxicchemotherapy reduce five year mortality (Early Breast CancerTrialist’s Collaborative Group, 1988). Yet, when trials wereconsidered individually, only a single trial had an effectsignificant at p <.01.

Inherently Implausible?

EHP 2006 can we bury

by James Coyne on Aug 27, 2012

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