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HYDREA is a medication that must be handled with care. People who are not taking HYDREA should not be exposed to it. If the powder from the capsule is spilled, it should be wiped up immediately with a damp disposable towel and discarded in a closed container, such as a plastic bag. The medication should be kept away from children and pets.

Table 3. Selected published data from HDC studies for patients with previously minimally treated metastatic disease prev. tx chemo sensitive ? induction + + + Type Study Phase II II II Preparative # rate Drugs Patients % ; Cy, CDDP, BCNU Cy, TT Cy, TT BCNU ; Cy, TT, Cb Cy, TT, Hydrea Ifos, Cb, VP16 Cyx2 Cy Carbo VP16 Cy, VP16, CDDP Dox, Cy, VP16 Cy, CDDP, TT Melph Cy, TT, Cb * Cy, VP16, CDDP 2 ; 22 24 rate % ; 23 54 27 rate % ; 77 100 71 TTP months ; 7.5 13 * 7.5 * 6 9 7.5 Overall Survival months from HDC ; 10 22 * 13 * 60% ; 22 Mortality rate % ; 23% 0 22 * 3 17 Figure 1. Top: immunohistochemical staining with breast marker BRST2 showing positivity in several tumor cells from cervical lymph node original X100 ; . Bottom: right lower lobe tumor biopsy specimen showingfocal cellsand cribriforminfiltrative arranged in sheets or clusters with gland patterns. Quences and amplicon size revealed 15 distinct amplicons, consistent with up to 15 independent amplification events. Which of these estimates is nearest to the truth? Microsatellite data may underestimate numbers of origins, if duplications have occurred independently on similar genetic backgrounds. Similarly, the number of amplicons could provide an overestimate because distinctive amplicons could be generated by recombination. Perhaps the best estimate comes from counting the number of independent 5# or 3# break point sequences because this will not be influenced by recombination. We found 8 distinct 5# break points and 10 distinct 3# break points. Furthermore, these estimates are derived from just 1 location. Genotyping of microsatellites immediately flanking pfmdr1 in infections collected from Mae la situated 120 km away from MawkerThai ; show that additional microsatellite backgrounds are associated with copy number amplification Uhlemann A-C, Anderson TJC, unpublished observations ; . Hence, our estimates almost certainly underestimate numbers of origins across Thailand or Southeast Asia and suggest that copy number change occurs very frequently. Selective events in which there have been multiple origins of the beneficial alleles have been termed ``soft'' sweeps Hermisson and Pennings 2005; Pennings and Hermisson 2006a, 2006b ; . A number of researchers have analyzed expected patterns of variation in markers flanking selected sites in such soft sweeps Innan and Kim 2004; Hermisson and Pennings 2005; Przeworski et al. 2005; Pennings and Hermisson 2006a, 2006b ; . Multiple origins of selected alleles are expected when mutation rates are high and populations are large. More precisely, multiple origins are expected when the population-level mutation parameter 2Nel . 0.01, where Ne is the effective population size and l is the per generation rate of mutation to the favorable allele. Estimates of both l and Ne are large in this case. We do not have direct estimates of the l for copy number change for P. falciparum. However, in Salmonella mutation rates may be as high as 102105 for copy number change in any region of the genome Anderson and Roth 1977; Romero and Palacios 1997 ; , whereas in Acinetobacter tandem amplifications underlying benzoate resistance arise at a frequency of ; 106 Reams and Neidle 2003 ; . Similarly, in eukaryotes, genome rearrangements occur at a frequency that is 12 orders of magnitude greater than point mutations Inoue and Lupski 2002; Repping et al. 2006 ; . Ne estimates from mtDNA sequence variation are ; 105 for Asian P. falciparum populations Joy et al. 2003 ; . Hence, with gene duplication rate conservatively estimated at 105106 and population based Ne of 105 estimates of the population mutation parameter 2Nel equals 0.22. Hence our observation of multiple independent origins is consistent with theory, if we assume biologically plausible mutation rate estimates. We use the theoretical framework developed by Pennings and Hermisson 2006a, 2006b ; to further explore how our empirical data conform to expectations. The expected reduction in He in the direct neighborhood of the selected locus is given by 1 ; Pennings and Hermisson 2006b, Equation 8 ; . The 42% reduction observed corresponds to a 2Nel of ; 1.4. Given estimates for Ne 105 ; and l 105106 ; , this seems plausible. Using an estimate of 1.4 for 2Nel, the theory also predicts the.

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