Prediction of Tumor Shrinkage in Acromegaly

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Brief Title

Prediction of Tumor Shrinkage in Acromegaly

Official Title

Predictive Value of 3 Months Results on 12 Months Tumor Shrinkage After First-Line Octreotide-LAR Therapy in Patients With Acromegaly

Brief Summary

      In the last two decades, somatostatin analogs have become a cornerstone of medical therapy
      for acromegaly. One year of treatment with octreotide-LAR (LAR) controls GH and IGF-I excess
      in 54% and 63% of unselected patients, with an increasing proportion of subjects achieving
      IGF-I normalization prolonging the treatment. Clinically significant tumor shrinkage (20-30%
      vs. baseline) has also been reported, with a higher proportion in patients treated first-line
      [231 of 448 patients (52%)] than in those treated after surgery and/or radiotherapy [52 of
      248 patients (21%)]. The highest rate of clinically significant shrinkage (>20%) occurred in
      patients treated first-line with LAR (80%) as compared to the short-lasting octreotide
      formulation (50%) or lanreotide slow-release formulation (35%. In 99 de novo patients with
      acromegaly, we recently reported control of GH levels in 57.6%, of IGF-I levels in 45.5% and
      a greater than 50% tumor shrinkage in 44.4% after 12 months of first-line treatment with
      somatostatin analogues, either LAR or lanreotide. Besides the different drug used, the
      duration of treatment also plays an important role on the shrinkage magnitude. In a
      homogeneous cohort of 56 patients treated with LAR only and continuously for 24 months, we
      noted an even more sustained effect on tumor shrinkage: overall, tumor volume decreased by
      68.1±16.5% using dosages up-titrated to 40 mg every 28 days.

      Despite this evidence, there is still a debate on the use of first-line treatment with
      somatostatin analogues. Of paramount importance would be the possibility to predict the
      results of one year treatment early after treatment beginning. Controversy has been reported
      on the predictive value of initial tumor size, inhibition of GH and IGF-I levels during
      treatment, and dose or type of the somatostatin analogue used during treatment. We found that
      percent suppression of IGF-I after 12 months of LAR treatment was the parameter that best
      predicted the amount of tumor shrinkage after the same period, but did not investigate the
      results of short-term treatment in the same series.

      This observational, analytical, open, retrospective study was designed to evaluate the
      predictive value of tumor shrinkage, GH and IGF-I suppression after 3 months of
      Octreotide-LAR (LAR) on tumor shrinkage obtained after 12 months. As secondary parameters we
      also studied baseline patients profile such as age of diagnosis, gender, estimated disease
      duration, GH and IGF-I levels and tumor size.
    

Detailed Description

      From Jan 1st 1995 to December 31st 2006, all files of patients with newly diagnosed active
      acromegaly out of the 297 patients coming to our Department for acromegaly who received
      first-line treatment with LAR will be considered for this study.

      As our routine procedure, all patients signed an informed consent to approve diagnostic
      testing, treatment decision, methods for follow-up and data treatment for scientific
      purposes. This study has been conducted in accordance with the Helsinki II Declaration on
      human experimentation. This study takes advantage from data collected in a large, prospective
      study to investigate the effect of first-line surgery or medical therapy (with somatostatin
      analogues and/or dopamine/agonists) on GH, IGF-I, tumor mass, cardiovascular risk markers,
      cardiomyopathy, hypertension, metabolic profile and prostate diseases in all the patients
      coming for a diagnosis of acromegaly in our Department and approved by our Ethical Committee
      the 14/10/97 (no.60/97).
    


Study Type

Observational


Primary Outcome

GH and IGF-I age-normalized levels, percent GH and IGF-I suppression and percent tumor shrinkage after 3 months

Secondary Outcome

 baseline age, gender, estimated disease duration, GH and IGF-I levels, tumor size

Condition

Acromegaly

Intervention

Octreotide-LAR

Study Arms / Comparison Groups

 A
Description:  Newly diagnosed active acromegaly out of the 297 patients coming to our Department for acromegaly who received first-line treatment with LAR

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

61

Start Date

January 1997

Completion Date

December 2007

Primary Completion Date

December 2007

Eligibility Criteria

        Inclusion Criteria:

          -  No previous treatment for acromegaly

        Exclusion Criteria:

          -  primary surgery

          -  concomitant hyperprolactinemia requiring combined somatostatin analogues and
             dopamine-agonist treatment

          -  primary treatment with lanreotide
      

Gender

All

Ages

18 Years - 85 Years

Accepts Healthy Volunteers

No

Contacts

Annamaria Colao, MD, , 

Location Countries

Italy

Location Countries

Italy

Administrative Informations


NCT ID

NCT00616408

Organization ID

NeuroendoUnit-8



Study Sponsor

Federico II University


Study Sponsor

Annamaria Colao, MD, Principal Investigator, University Federico II of Naples


Verification Date

December 2007