DERIVATION OF VALIDATING SAMPLE

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DERIVATION OF VALIDATING SAMPLE


Tumor growth rates have a great prognostic impact, especially
for the early
-
stage breast tumors most often treated with adjuvant
tamoxifen therapy (Osborne, 1989). The core of the framework used
to analyze tamo
xifen effects is the relapse rates for untreated
"good risk" patients (with node
-
negative, estrogen
-
receptor posi
-
tive, < 3 cm tumors) reported by Clark et al (1992). (See appended
array based on their 0.87 correlation between SPF and relapse risk
among di
ploid tumors and their 0.66 correlation among aneuploid
tumors.) The risk of relapse in higher
-
risk patients parallels the
Milan findings reported by Valagussa et al (1978). Linkages to SPF
for these groups are taken from studies by Dressler et al (1988),
Fisher et al (1991), and Silvestrini et al (1979).


In validation comparisons the basic array of 1000 patients is
truncated to match the 666 in the Scottish 15
-
year tamoxifen trial
(Stewart et al, 2001). The upper end of the age range is 70, to
match the
cutoff in NSABP Trial B
-
14 (Fisher et al, 1989, 1996,
2001); this eliminates a disproportionate amount of slower
-
growing
tumors (Meyer et al, 1986). The size ceiling for node
-
negative
tumors is set at 5.3 cm to match the proportion larger than 2.0 cm
in N
SABP Trial B
-
14. Patients with more than eight involved nodes
are left out to match the ratio between 1
-
3 nodes and 4+ nodes in
the GUN Trials (Bianco et al, 1988, 1998, 2000).


The validation closely matches results from NSABP Trial B
-
14;
Early Breast Can
cer Trialists' Collaborative Group (1992) trends
are used to extend these findings to node
-
positive and ER
-
negative
groups. The GUN Trials, the Swedish trials (Rutqvist et al, 1987;
Swedish Breast Cancer Cooperative Group, 1996) and the NATO trial
(Nolvad
ex Adjuvant Trial Organization, 1988) contribute data for
both nodal and ER categories.





rank

Dip.SPF

Aneu.SPF

5YrRel

rank

Dip.SPF

Aneu.SPF

5YrRel


99 11.90% 26.66% 71.61% 49 3.56% 7.67% 18.30%


98 10.85% 24.28% 64.93%

48 3.48% 7.50% 17.82%


97 10.13% 22.63% 60.32% 47 3.41% 7.33% 17.34%


96 9.58% 21.39% 56.82% 46 3.33% 7.16% 16.86%


95 9.13% 20.37% 53.96% 45 3.26% 6.99% 16.39%


94 8.76% 19.
52% 51.57% 44 3.18% 6.82% 15.91%


93 8.47% 18.78% 49.51% 43 3.11% 6.65% 15.43%


92 8.16% 18.16% 47.76% 42 3.06% 6.53% 15.12%


91 7.94% 17.65% 46.33% 41 2.98% 6.36% 14.64%


90

7.74% 17.19% 45.06% 40 2.93% 6.25% 14.32%



89 7.57% 16.79% 43.94% 39 2.89% 6.14% 14.00%


88 7.42% 16.45% 42.99% 38 2.84% 6.02% 13.68%


87 7.24% 16.06% 41.88% 37 2.79% 5.91% 1
3.37%


86 7.09% 15.72% 40.92% 36 2.74% 5.79% 13.05%


85 6.94% 15.38% 39.97% 35 2.69% 5.68% 12.73%



84 6.82% 15.09% 39.17% 34 2.64% 5.57% 12.41%


83 6.69% 14.81% 38.38% 33 2.59%

5.45% 12.09%


82 6.58% 14.53% 37.58% 32 2.54% 5.34% 11.78%


81 6.44% 14.24% 36.79% 31 2.49% 5.23% 11.46%


80 6.32% 13.96% 35.99% 30 2.44% 5.11% 11.14%



79 6.22% 13.73% 35.36%

29 2.39% 5.00% 10.82%


78 6.12% 13.51% 34.72% 28 2.34% 4.89% 10.50%


77 6.01% 13.23% 33.92% 27 2.29% 4.77% 10.19%


76 5.91% 13.00% 33.29% 26 2.24% 4.66% 9.87%


75 5.81% 12.77%

32.65% 25 2.19% 4.55% 9.55%



74 5.71% 12.55% 32.02% 24 2.14% 4.43% 9.23%


73 5.61% 12.32% 31.38% 23 2.09% 4.32% 8.91%


72 5.51% 12.10% 30.74% 22 2.04% 4.21% 8.60%


71 5.
41% 11.87% 30.11% 21 1.99% 4.09% 8.28%


70 5.31% 11.64% 29.47% 20 1.94% 3.98% 7.96%



69 5.21% 11.42% 28.84% 19 1.89% 3.87% 7.64%


68 5.11% 11.19% 28.20% 18 1.84% 3.75% 7.3
2%


67 5.01% 10.97% 27.57% 17 1.79% 3.64% 7.01%


66 4.91% 10.74% 26.93% 16 1.74% 3.53% 6.69%


65 4.83% 10.57% 26.25% 15 1.69% 3.41% 6.37%



64 4.73% 10.35% 25.82% 14 1.64%

3.30% 6.05%


63 4.63% 10.12% 25.18% 13 1.57% 3.13% 5.58%


62 4.55% 9.94% 24.70% 12 1.52% 3.02% 5.26%


61 4.45% 9.71% 24.07% 11 1.44% 2.85% 4.78%


60 4.38% 9.54% 23.59% 10

1.39% 2.73% 4.46%



59 4.30% 9.37% 23.11% 9 1.32% 2.56% 3.98%


58 4.23% 9.20% 22.64% 8 1.27% 2.45% 3.67%


57 4.15% 9.03% 22.16% 7 1.19% 2.28% 3.19%


56 4.08% 8.86% 2
1.63% 6 1.14% 2.17% 2.87%


55 4.01% 8.69% 21.19% 5 1.06% 2.00% 2.40%


54 3.93% 8.52% 20.70% 4 0.99% 1.83% 1.92%


53 3.86% 8.35% 20.21% 3 0.92% 1.66% 1.44%


52 3.78%

8.18% 19.73% 2 0.84% 1.49% 0.96%


51 3.71% 8.01% 19.25% 1 0.77% 1.32% 0.49%


50 3.63% 7.84% 18.77% 0 0.70% 1.15% 0.01%






i


REFERENCES


Bianco

AR, De Placido S, Gallo C, Pagliarulo C, Marinel
li A, Pet
-
rella G, et al
(1988)
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Breast Cancer.
Lancet

1988(2):1095
-
1099.


Bianco

AR, De Laurentiis M, Carlomagno C, Lauria R, Petrella G,
Panico L, et al
(1998)
: 20 Year Update of the Naples GUN Trial of
Adjuvan
t Breast Cancer Therapy: Evidence of Interaction Between c
-
erb
B
-
2 Expression and Tamoxifen Efficacy (abstract 373).
Proc ASCO

17:97a.


Bianco

AR, De Laurentiis M, Carlomagno C, Gallo C, Panico L, De
Placido S
(2000)
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amoxifen
(TAM) Failure for Early Breast Cancer (EBC): Complete Data at 20
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Proc ASCO

19:75a.


Clark

GM, Mathieu MC, Owens MA, et al
(1992)
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Phase Fraction in Good
-
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LG, Seamer LC, Owens MA, Clark GM, and McGuire WL
(1988)
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-
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B, Costanti
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ii

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