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AUSL 4 Prato

Geriatric Oncology

Misericordia e Dolce Hospital,
Piazza Ospedale - 59100 Prato
Tel: 0574/434766 Fax: 0574/29798

Principal Investigator: Dr. Laura Biganzoli

Staff

  • Dr. Andrea Ciarlo, oncologist and geriatrician;
  • Dr E Zafarana, post doc;
  • Dr Sara Licistra, post doc;
  • Dr C Biagioni, data manager;
  • Mr S Anderini, nurse
  • Dr G Mottino, geriatrician

Cancer is predominantly a disease of the elderly: approximately 60% of all tumors and two thirds of cancer-related deaths occur in the over 65 population. This proportion will grow with the expected increase in the size of the older population in the coming decades. For example, if incidence rates remain constant, the number of elderly women diagnosed with breast cancer in the US will increase by 72% by 2025 [1].
Adequate directives for the treatment of this important group of patients are often lacking, because the elderly have generally been excluded from clinical trials. In an analysis of EORTC phase II enrollment only 22% of patients were 65 years or older and 8% were 70 years or older ; a later Eastern Cooperative Group trial enrollment report stated that from 1998-1999, about 35% of trial participants were 60 years of age or older and only about 17% were 70 or older [2,3]. Possible reasons for poor participation include the following: few trials are specifically designed for elderly patients; physicians, patients and family members may think that older patients are less likely to benefit from and less able to tolerate appropriately intensive treatment; the elderly may be less aware of medical developments and less likely to seek out clinical trials; older people more often have other health problems (co-morbidities); and there is lack of financial, logistic and social support for participation of older patients in trials. There is substantial evidence to indicate that, with a range of tumor types, elderly patients have a relative survival similar to that of younger patients when given comparable treatments [4-6]. However, a number of studies have shown that elderly patients often have more advanced disease at the time of diagnosis and receive fewer intensive treatments [7-12]. There is therefore concern that elderly patients frequently receive inadequate treatment.
In addition, aging is associated with a progressive decline in the functional reserve of multiple organ systems. In turn, this is responsible for an increased prevalence of co-morbidities and functional dependence in the older population, with a consequent reduction in the tolerance of stress, including cytotoxic chemotherapy. These changes influence treatment-related decision-making for older individuals because they imply a decrease in life expectancy and tolerance of cancer treatment. Currently, the best estimates of individual functional reserve and life expectancy may be provided by a comprehensive geriatric assessment (CGA). A full CGA includes the assessment of function, co-morbidity, socioeconomic conditions, cognition, emotional conditions, pharmacy, nutrition, and geriatric syndromes [13].
By the mean of a CGA is possible to identify three subgroups of elderly patients: healthy, vulnerable and frail. Theoretically healthy older cancer patients should be treated as younger patients and frail patients are no candidates for antiblastic treatments. A strong collaboration with geriatrician is recommended for vulnerable patients to put in place rehabilitative procedures that could ameliorate treatment compliance.

References

  1. Alberg AJ, Singh S. Epidemiology of breast cancer in older women: implications for future healthcare. Drugs Aging 2001; 18: 761-772
  2. Facts and figures about cancer clinical trials. http://www.nci.nih.gov/clinicaltrials/facts-and-figures
  3. Monfardini S, Sorio R, Boes GH, Kaye S, Serraino D. Entry and evaluation of elderly patients in European Organization for Research and Treatment of Cancer (EORTC) new-drug-development studies.Cancer 1995 ;76:333-8
  4. Begg CB and Carbone PP. Clinical trials and drug toxicity in the elderly. The experience of the Eastern Cooperative Oncology Group. Cancer 1983; 52:1986-1992
  5. Dhodapkar MV, Ingle JN, Cha SS et al. Prognostic factors in elderly women with metastatic breast cancer treated with tamoxifen: an analysis of patients entered on four prospective trials. Cancer 1996; 77: 683-690
  6. Siu LL, Shepherd FA, Murray N et al. Influence of age on the treatment of limited-stage small-cell lung cancer. J Clin Oncol 1996; 14: 821-828
  7. Bush E, Kemeny M, Fremgen A et al. Patterns of breast cancer care in the elderly. Cancer 1996; 78: 101-111
  8. Bergman L, Kluck HM, van Leeuwen FE et al. The influence of age on treatment choice and survival of elderly breast cancer patients in south-eastern Netherlands: a population-based study. Eur J Cancer 1992; 28a: 235-244
  9. Goodwin JS, Samet JM and Hurt WC. Determinants of survival in older cancer patients. J Natl Cancer Inst 1996; 88: 1031-1037
  10. Newcomb PA and Carbone PP. Cancer treatment and age: patient perspectives. J Natl Inst 1993; 85: 1580-1584
  11. Higtower RD, Nguyen HN, Averette HE et al. National survey of ovarian carcinoma. IV: Patterns of care and related survival for older patients. Cancer 1994; 73: 377-383
  12. Newschaffer CJ, Penberthy L, Desch CE et al. The effect of age and comorbidity in the treatment of elderly women with nonmetastatic breast cancer. Arch Intern Med 1996; 156: 85-90
  13. Balducci L, Extermann M. Management of cancer in the older person: a practical approach. The Oncologist 2000; 5: 224-237

Main Research Themes

  1. Communication, information and adaptation to antiblastic treatment and its side effects in elderly patients. (1 year - completed)
  2. The effect of chemotherapy on the functional reserve of elderly cancer patients. A coordinated-multidisciplinary evaluation (3 years)
  3. Adjuvant capecitabine in elderly patients with breast cancer : a phase II study. (2 years)
  4. Chemotherapy Adjuvant Studies for women at advanced Age (CASA) – IBCSG 32 – 05/BIG 1-05. (3-4 years)
  5. Prediction of cardiac toxicity in older breast cancer patients treated with anthracyclines. (2-3 years)

Clinical Trials

  1. Communication, information and adaptation to antiblastic treatment and its side effects in elderly patients
    Data analysis is ongoing
  2. The effect of chemotherapy on the functional reserve of elderly cancer patients. A coordinated-multidisciplinary evaluation.
    Accrual is ongoing. Preliminary analysis planned 1st half 2007
  3. Adjuvant capecitabine in elderly patients with breast cancer : a phase II study
    Data have been presented at international meetings:
    Bernard C, Personeni N, Demonty G, Cardoso F, Kabanga E, Beddegenoots V, Lebrun F, Mancini I, Bexon A, Nogaret JM, Paesmans M, Biganzoli L, Piccart MJ. A phase II study of Capecitabine monotherapy for elderly patients (pts) with high risk early breast cancer (BC). 6th SIOG Annual Meeting, Geneva September 29-October 1, 2005 –Poster display, poster n.55
    Bernard-Marty C, Demonty G, Personeni N, Ismael G, Cardoso F, Kabanga E, Bexon A, Nogaret JM, Biganzoli L, Piccart MJ. Capecitabine as adjuvant therapy for elderly breast cancer (BC) patients (pts): A pilot study. Eur J Cancer 4 (Suppl): 154, 2006 (abs 364)
  4. Phase III Trials Evaluating the Role of Adjuvant Pegylated Liposomal Doxorubicin (PLD, Caelyx®) for Women (age 66 years or older) with Endocrine Nonresponsive Breast Cancer Who Are NOT Suitable for being offered a "Standard Chemotherapy Regimen"
    Ongoing
  5. Variation of the metabolic profiles in serum and urines as predictors of cardiac toxicity in breast cancer patients receiving adjuvant antracyclines.
    Ongoing

Publications

  1. Biganzoli L and Aapro M. Adjuvant chemotherapy in the elderly. Educational book -ESMO Summer Educational Conference 2003. Ann Oncol 14 (Suppl 3):iii1-iii3, 2003
  2. Paridaens R, Dirix L, Lohrisch C, Beex L, Nooij M, Cameron D, Biganzoli L, Cufer T, L Duchateau, Hamilton A, Lobelle JP, Piccart M. Mature Results of a Randomized Phase II Multi-centre Study of Exemestane Versus Tamoxifen as First Line Hormone Therapy for Postmenopausal Women with Metastatic Breast Cancer. Ann Oncol 14 (9): 1391-1398, 2003
  3. Repetto L, Biganzoli L, Koehne CH, Luebbe AS, Soubeyran P, Tjan-Heijnenf VCG. EORTC guidelines for the use of colony-stimulating factors in elderly patients with cancer. Eur J Cancer 39: 2264-2272, 2003
  4. Atalay G, Dirix L, Biganzoli L, Beex L, Nooij M, Cameron D, Lohrisch C, Cufer T, Lobelle JP, Mattiaci MR, Piccart M and Paridaens R. The effect of exemestane on serum lipid profile in postmenopausal women with metastatic breast cancer: A companion study to EORTC Trial 10951-,“Randomized phase II study in first line hormonal treatment for metastatic breast cancer with exemestane or tamoxifen in postmenopausal patients. Ann Oncol 15: 211-217, 2004
  5. Biganzoli L, Goldhirsch A, Straehle C, Castiglione M, Therasse P, Vogt G, Aapro M, Minisini A, and Piccart MJ. Adjuvant chemotherapy in elderly patients with breast cancer: a survey of the Breast International Group (BIG). Ann Oncol 15: 207-210, 2004
  6. Minisini AM, Atalay G, Bottomley A, Puglisi F, Piccart M, and Biganzoli L. What is the impact of systemic anticancer treatments on cognitive functioning? Lancet Oncol 5:273-282, 2004
  7. Biganzoli L, Untch M, Skacel T, and Pico JL. Neulasta® (pegfilgrastim): a once-per-cycle option for the management of chemotherapy-induced neutropenia (CIN). Sem Oncol 31 S8: 27-34, 2004
  8. Biganzoli L, Aapro M, Balducci L, Minisini A, Piccart M. Adjuvant therapy in elderly breast cancer patients. Clin Breast Cancer 5: 188-195, 2004
  9. Minisini A, Spazzapan S, Crivellari D, Aapro M, Klastersky JK and Biganzoli L. Incidence of febrile neutropenia and neutropenic infections in elderly patients receiving anthracycline-based chemotherapy for breast cancer without primary prophylaxis with colony-stimulating factors. Crit Rev Oncol Hematol 53:125-131, 2005
  10. Biganzoli L, Aapro M. Elderly breast cancer patients: adjuvant chemotherapy and adjuvant endocrine therapy. Gynakol Geburtshilfliche Rundsch. 45:137-42, 2005
  11. Biganzoli L, Aapro M. Traitement adjuvant du cancer du sein chez la patiente agée. Ref Ginecol Obstet 11 : S247-S251, 2005
  12. Biganzoli L, Coleman R, Minisini A, Hamilton A, Aapro M, Therasse P, Mottino G, Bogaerts J, Piccart M. A joined analysis of two European Organization for the Research and Treatment of Cancer (EORTC) studies to evaluate the role of pegylated liposomal doxorubicin (Caelyx) in the treatment of elderly patients with metastatic breast cancer. Crit Rev Oncol Hematol 61: 84-9; 2007 .
  13. Muss H, Biganzoli L, Sargent D, Aapro M. Adjuvant Therapy in the Elderly: Making the Right Decision. J Clin Oncol 25: 1870-5; 2007
  14. Biganzoli L, Licitra S, Claudino W, Pestrin M, Di Leo A. Clinical decision making in breast cancer: TAM and aromatase inhibitors for older patients - a jungle? Eur J Cancer. 2007 Aug 13; [Epub ahead of print]

Books chapters

  1. Di Leo A., Biganzoli L. Carcinoma della mammella. In Terapia Medica Oncologica 2001, Armando Santoro ed, 2001. pg 519-544
  2. Biganzoli L, Ciarlo A, Mottino G, Gavazzano A. La malattia avanzata nella donna anziana. In Oncoform-programma di formazione in oncologia. Corso 2. Neoplasie della mammella in fase avanzata. Centro Scientifico ed., 2004. pg13-20

Collaborations

  • U.O. Geriatria — Ospedale di Prato
  • GIOGER (Gruppo Italiano di Oncologia Geriatria)
  • Jules Bordet Institute, Bruxelles, Belgium
  • IBCSG (International Breast Cancer Study Group)
  • BIG (Breast International Group)
  • EORTC (European Organisation for Research and Treatment of Breast Cancer)
  • Centro di Riferimento Oncologico - Aviano
  • INRCA (Istituto Nazionale Riposo e Cura Anziani) – Roma
  • Center for Magnetic Resonance, Scientific Pole, Università di Firenze, Sesto Fiorentino, Firenze

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